Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202105817814362 Date of Approval: 24/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern. (Currently on Ubuntu Version 8.0 Amendment 7.0)
Official scientific title Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern
Brief summary describing the background and objectives of the trial Evaluating the effectiveness of mRNA vaccines, including bivalent vaccines, against COVID-19 from VOCs among PLWH. By collecting efficacy and safety data in over half-a-dozen countries across sub-Saharan Africa, the study authors hope to inform regulators in the region and help facilitate access to mRNA vaccine technology across Africa. Objectives: PRE–MONTH 6 STAGE: to assess the relative risk of virologically confirmed symptomatic COVID-19 between a 2-dose mRNA-1273 vaccine regimen in adult people living with HIV (PLWH) who are SARS-CoV-2 negative at baseline(Group 1, vaccine-only immunity) vs. a 1-dose mRNA-1273 regimen in adult PLWH who are SARS-CoV-2 positive at baseline (Group 2, hybrid immunity), counting endpoints starting 1 day after Month 0 dose until Month 6 dose. PRE–MONTH 6 STAGE: to assess the relative risk of severe COVID-19 between a 2-dose mRNA-1273 vaccine regimen in adult PLWH who are SARS-CoV-2 negative at baseline (Group 1, vaccine-only immunity) vs. a 1-dose mRNA-1273 regimen in adult PLWH who are SARS-CoV-2 positive at baseline (Group 2, hybrid immunity), counting endpoints starting 1 day after Month 0 dose until Month 6 dose POST–MONTH 6 STAGE: to assess the relative risk of symptomatic COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. Primary objective 4: POST–MONTH 6 STAGE: to assess the relative risk of severe COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. To assess the safety and tolerability of the mRNA-1273 and mRNA-1273.222vaccines in adults who are at risk of severe COVID-19 in both pre-Month 6 and post-Month 6 stages
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COVPN 3008
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID 19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 14/06/2021
Actual trial start date 13/07/2021
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 15600
Actual target sample size (number of participants) 14232
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mRNA 1273 Approximately 14,000 participants will be randomized to immediate vaccinations of two doses of COVID-19 mRNA vaccine at Months 0 and 1, or deferred vaccinations at the crossover visit approximately 3.5 months later. A 1 to1 allocation ratio is used 7,000 immediate vaccination, 7,000 deferred vaccination. All participants will receive vaccine during this trial. At the first set of vaccinations -Month 0 and Month 1- immediate vaccine recipients will receive vaccine injections and deferred vaccine recipients will receive placebo injections. We anticipate that all participants in this trial will receive vaccine before it becomes available in their community. If the vaccine becomes available, participants will have the option of being unblinded and receiving vaccine out of study. The blinded crossover entails that deferred vaccine recipients will be crossed over to vaccine in a blinded fashion all participants will receive two additional injections one month apart, with the deferred vaccine group receiving vaccine injections and the immediate vaccine group receiving placebo injections. The study design is such large sample size and 1:1 randomization ratio that the time from placebo injection to injection with active product for participants in the deferred vaccination group is as short as possible. We anticipate an enrollment period of 2 months. The average follow up time prior to crossover at 4 months is approximately 3 months, with 4 months for the first enrollee and 2 months for the last enrollee. 18 months mRNA 1273 vaccine 7000
Control Group mRNA 1273 deferred vaccine Approximately 14 000 participants will be randomized to immediate vaccinations of two doses of COVID-19 mRNA vaccine at Months 0 and 1, or deferred vaccinations at the crossover visit approximately 3.5 months later. A 1 to 1 allocation ratio is used 7,000 immediate vaccination, 7,000 deferred vaccination. All participants will receive vaccine during this trial. At the first set of vaccinations Month 0 and Month 1, immediate vaccine recipients will receive vaccine injections and deferred vaccine recipients will receive placebo injections. We anticipate that all participants in this trial will receive vaccine before it becomes available in their community. If the vaccine becomes available, participants will have the option of being unblinded and receiving vaccine out of study. The blinded crossover entails that deferred vaccine recipients will be crossed over to vaccine in a blinded fashion: all participants will receive two additional injections one month apart, with the deferred vaccine group receiving vaccine injections and the immediate vaccine group receiving placebo injections. 18 months COVID 19 deferred vaccine 7000 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
General and Demographic Criteria 1. Age ≥ 18 years if participant self-reports living with HIV or another comorbidity known to be associated with severe COVID-19, for example (CDC.gov for exhaustive list): • Hypertension • Type 2 diabetes mellitus • Overweight, obese, or severely obese (ie, body mass index [BMI] ≥ 25 kg/m2 ) • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies • Chronic kidney disease • COPD (chronic obstructive pulmonary disease) • Cancer Non-HIV immunocompromised state (weakened immune system) or solid organ transplant • Pregnancy • Sickle cell disease • Smoking 2. Willingness to be followed and remain in the catchment area for the planned duration of the study. 3. Ability and willingness to provide informed consent. 4. Willingness to discuss HIV infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize HIV acquisition/improve HIV care as appropriate based on their infection status. 5. Assessment of Understanding (AoU): Participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly. 6. Agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease. General 1. Acutely ill 72 hours prior to or at screening. Participants meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator. 2. History of angioedema or anaphylaxis. Vaccines and other injections 1. Prior receipt of a SARS-CoV-2 vaccine. 2. History of severe allergic reaction to any ingredient of this vaccine (lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), CoVPN 3008 (Ubuntu) Version 8.0 / June 28, 2023 CoVPN3008_v8.0_Final_28June23 / Page 61 of 169 tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose). 3. Live attenuated vaccines received within 30 days before first vaccination (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine, live attenuated zoster vaccine). 4. Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, human papilloma virus (HPV), pneumococcal, Hepatitis A or B). 5. Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination. Adult: 19 Year-44 Year 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/07/2021 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office UKZN Mazisi Kunene Road, Glenwood Durban South Africa Durban 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/07/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2021 Sefako Makgatho University Research Ethics Committee SMUREC
Ethics Committee Address
Street address City Postal code Country
Sefako Makgatho Health Sciences University Molotlegi Street, Ga-Rankuwa Pretoria Gauteng Pretoria 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/06/2021 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road Lyttelton Manor Centurion Pretoria South Africa Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/06/2021 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive Parowvallei 7505 Cape Town, South Africa Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/07/2021 University of Stellenbosch Health Research Ethics
Ethics Committee Address
Street address City Postal code Country
Health Research Office Stellenbosch University Tygerberg Campus Research Development and Support Division Room 5008A Tygerberg Campus Education Building Francie van Zijl Drive Tygerberg Stellenbosch Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/07/2021 University of Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue Parktown Johannesburg South Africa Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2021 JREC Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences
Ethics Committee Address
Street address City Postal code Country
Mt Pleasant Harare 11111 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2021 NBAZ National Biotechnology Authority of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
21 Princess Drive, Newlands Harare 11111 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/07/2021 UCSF Human Research Protection Program IRB
Ethics Committee Address
Street address City Postal code Country
San Francisco General Hospital, 490 Illinois Street, Floor 6, San Francisco 94143 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/06/2021 SAHPRA South African Health Products Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Building A Loftus Park, 402 Kirkness Street, Arcadia, Pretoria 0001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/07/2021 Kemri Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
KENYA MEDICAL RESEARCH INSTITUTE SCIENTIFIC AND ETHICS REVIEW UNIT HOUSE NUMBER 8, KEMRI HEADQUARTERS P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI, KENYA NAIROBI NONE Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/08/2021 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
PRIVATE BAG 0038, GABORONE BOTSWANA GABORONE 0000 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2021 The Uganda Virus Research Institute Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road Entebbe P O Box 49 Entebbe Uganda ENTEBBE 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 Uganda Virus Institute Ethics Committee UVRI
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 , Nakiwogo Road Entebbe , Uganda Entebbe None Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 Uganda Virus Research Institute UVRI
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road Entebbe Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 Uganda Virus Research Institute UVRI
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road Entebbe Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 Uganda Virus Research Institute UVRI
Ethics Committee Address
Street address City Postal code Country
PLOT 51-59 Nakiwogo Road Entebbe Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/10/2021 Botswana Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park Gaborone Botswana Gaborone 0000 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2021 Joint Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
JREC Office , No 4 5th Floor Faculty of Medicine , University of Zimbabwe Harare Harare 0000 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2021 National Biotechnology Authority of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
21 Princess Drive Newlands Harare Harare 0000 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/09/2021 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Pediatric Centre for Excellence Harare 0000 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/09/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat office Kampala P. O Box 23096, Kampala, Uganda Plot 19 Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/10/2021 University of North Carolina Chapel Hill Office of Human Research Ethics
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King Jr Boulevard Building 385 2nd Floor CB 7097 Chapel Hill NC Chapel Hill 27599709 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/10/2021 Kenya Medical Research InstituteEthics Commitee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840-00200, NAIROBI. Kenya Nairobi 0000 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/08/2021 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Private Bag 0038 Gaborone Botswana Gaborone 0000 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2021 National Biotechnology Authority
Ethics Committee Address
Street address City Postal code Country
21 Princess Drive Newlands Harare Zimbabwe Harare 0000 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2021 Uganda Virus Research Institute
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road Entebbe Uganda Entebbe 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2021 Uganda Virus Research Institute UVRI JCRC Approval
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwongo Road Entebbe Uganda Entebbe 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/11/2021 Eswatini Health and Human Research Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health 3rd Floor Mbandzeni House Mbabane Eswatini Mbabane 0000 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2021 Kenya Pharmacy and Poison Board
Ethics Committee Address
Street address City Postal code Country
PHARMACY AND POISONS BOARD HOUSE LENANA ROAD NAIROBI P O BOX 27663 00506 NAIROBI Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/12/2021 Moi University Institutional Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Moi University College of Health Science P O Box 4606 Eldoret Kenya Eldoret N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2021 Kenya Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
Kenya Medical Research Institute P O Box 54840 00200 Off Raila Odinga Way. Nairobi Kenya Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2021 Pharmacy and Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority Off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/11/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Avenue Kampala Uganda Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/11/2021 National Drug Authority Baylor
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Avenue Kampala Uganda Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2021 Uganda Virus Research Institute Baylor
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute 51-59 Nakiwogo Road Entebbe Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2021 Uganda Virus Research Institute JCRC approval
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute 51-59 Nakiwogo Road Entebbe Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2021 Uganda Virus Research Institute MUJHU Version 4
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute 51-59 Nakiwogo Road Entebbe Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2021 Uganda Virus Research Institute
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute 51-59 Nakiwogo Road Entebbe Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/11/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Uganda National Council for Science and Technology Plot 6 Kimera Road Ntinda P O Box 6884 KAMPALA, UGANDA Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Uganda National Council for Science and Technology Plot 6 Kimera Road Ntinda P O Box 6884 KAMPALA, UGANDA Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/12/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Zambia Medicines Regulatory Authority Plot No 2350/M P O Box 31890 Lusaka Zambia Lusaka N/A Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/09/2021 National Bioethics Authority
Ethics Committee Address
Street address City Postal code Country
National Bioethics Authority Off Kafue Road Mount Makulu Chilanga Lusaka Zambia Lusaka N/A Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2021 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Paediatric Centre of Excellence University Teaching Hospital Chalala Office Lot No 18961/M Off Kasama Lusaka Zambia Lusaka N/A Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2022 Uganda Virus Research Ethics
Ethics Committee Address
Street address City Postal code Country
Plot 51059, Nakiwogo Road Entebbe 31405 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2022 Uganda Virus Research Institute
Ethics Committee Address
Street address City Postal code Country
51 to 59 Nakiwogo Road Entebbe 31405 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2022 Uganda Virus Research Institute
Ethics Committee Address
Street address City Postal code Country
51 to 59 Nakiwogo Road Entebbe 31405 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2022 Uganda Virus Research Institute
Ethics Committee Address
Street address City Postal code Country
51 to 59 Nakiwogo Road Entebbe 31405 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/03/2022 Wits Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 Jan Smuts Avenue Johannesburg x2600 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/04/2022 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
491 Peter Mokaba Ridge Road Durban 4091 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2022 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
491 Peter Mokaba Ridge Road Durban 4091 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/01/2022 Kenya Medical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
KNH Mbagathi Road Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2022 University of Stellenbosch Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7602 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 University of Stellenbosch Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7602 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2021 University of Stellenbosch Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7502 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/04/2022 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi P O Box 27663 00506 Nairobi 27663 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/12/2021 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Lenana Road Nairobi Nairobi 00506 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/11/2021 Columbia University IRB
Ethics Committee Address
Street address City Postal code Country
154 Haven Road First Floor 615 West 131st Street 3rd Floor New York 10032 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/06/2021 Columbia University IRB
Ethics Committee Address
Street address City Postal code Country
154 Haven Road First Floor 615 West 131st Street 3rd Floor New York 10032 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/01/2022 Columbia University IRB
Ethics Committee Address
Street address City Postal code Country
154 Haven Road First Floor 615 West 131st Street 3rd Floor New York 10032 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/07/2021 Eswatini Health and Human Research Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Mbandzeni House, 3rd Floor, Mbabane, Eswatini Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/03/2022 Eswatini Health and Human Research Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Mbandzeni House, 3rd Floor, Mbabane, Eswatini Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/11/2021 Eswatini Health and Human Research Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Mbandzeni House, 3rd Floor, Mbabane, Eswatini Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2021 University of North Carolina at Chapel Hill Biomedical IRB
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King, Jr. Blvd. North Carolina 27599-709 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/10/2021 University of North Carolina at Chapel Hill Biomedical IRB
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King, Jr. Blvd. North Carolina 27599-709 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/03/2021 University of North Carolina at Chapel Hill Biomedical IRB
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King, Jr. Blvd. North Carolina 27599-709 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/07/2021 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/03/2022 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C.O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/07/2021 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Road Campus Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/10/2021 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Road Campus Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/02/2022 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Road Campus Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/10/2021 Harvard IRB
Ethics Committee Address
Street address City Postal code Country
90 Smith Street, 3rd Floor Cambridge 02120 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/06/2021 Harvard IRB
Ethics Committee Address
Street address City Postal code Country
90 Smith Street, 3rd Floor Cambridge 02120 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/12/2021 Harvard IRB
Ethics Committee Address
Street address City Postal code Country
90 Smith Street, 3rd Floor Cambridge 02120 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/08/2021 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Government EnclavePlot No. 54609 Gaborone Botswana Gaborone 0038 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2021 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Government EnclavePlot No. 54609 Gaborone Botswana Gaborone 0038 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/12/2021 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Government EnclavePlot No. 54609 Gaborone Botswana Gaborone 0038 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/07/2021 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C.O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/03/2022 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C.O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/08/2021 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue Parktown Johannesburg South Africa Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/10/2021 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue Parktown Johannesburg South Africa Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/03/2022 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue Parktown Johannesburg South Africa Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road Lyttelton Manor Centurion Pretoria East Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/10/2021 Phama Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road Lyttlelton Manor Centurion Pretoria South Africa Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/03/2022 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123Amkor Road Lyttelton Manor Centurion Pretoria South Africa Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/07/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/09/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/07/2022 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/09/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/07/2021 UCT Health Science Faculty Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/09/2021 UCT Health Science Facultyy Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2021 UCT Health Science Faculty Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/07/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/09/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2021 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2021 Harvard IRB
Ethics Committee Address
Street address City Postal code Country
90 Smith Street, 3rd floor Cambridge 02120 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/04/2022 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Government Enclave Plot No. 54609 Gaborone Botswana Gaborone CRS 0038 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/06/2021 Botswana Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park, Gaborone Gaborone 2 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/10/2021 Botswana Medical Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park, Gaborone Gaborone 2 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/01/2022 Botswana Medical Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park, Gaborone Gaborone 2 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/03/2022 Botswana Medical Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park, Gaborone Gaborone 2 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/08/2021 SAHPRA South African Health Products Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Building A Loftus Park, 402 Kirkness Street, Arcadia Pretoria 0001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2021 SAHPRA South African Health Products Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Building A Loftus Park 402 Kirkness Street Arcadia Pretoria 0001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/03/2022 SAHPRA South African Health Products Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Building A Loftus Park, 402 Kirkness Street, Arcadia Pretoria 0001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/04/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Rd, Kampala Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Uganda National Council for Science and Technology Plot 6 Nimera Road Ntinda Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/09/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Plot 19 Lumumba Avenue opposite TWED plaza Kampala 23096 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Uganda National Council for Science and Technology Plot 6 Nimera Road Ntinda Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Uganda National Council for Science and Technology Plot 6 Nimera Road Ntinda Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/09/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Plot 19 Lumumba Avenue opposite TWED Plaza Kampala 23096 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/09/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Plot 19 Lumumba Avenue opposite TWED Plaza Kampala 23096 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/09/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/11/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Avenue Kampala Uganda Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/09/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Avenue Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/11/2021 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Avenue Kampala Uganda Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/11/2021 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2021 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, UKZN Mazisi Kunene Road, Glenwood Durban South Africa Durban 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2021 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office UKZN Mazisi Kunene Road, Glenwood Durban South Africa Durban 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/08/2021 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office UKZN Mazisi Kunene Road, Glenwood Durban South Africa Durban 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2021 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office UKZN Mazisi Kunene Road, Glenwood Durban South Africa Durban 4004 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 Sefako Makgatho University Research Ethics Committee SMUREC
Ethics Committee Address
Street address City Postal code Country
Sefako Makgatho Health Sciences University Mototlegi Street, Ga-Rankuwa Pretoria Gauteng2712 Pretoria 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2021 Sefako Makgatho University Research Ethics Committee SMUREC
Ethics Committee Address
Street address City Postal code Country
Sefako Makgatho Health Sciences University, Mototlegi Street, Ga-Rankuwa Pretoria Gauteng Pretoria 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/09/2021 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/01/2022 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/12/2021 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Pediatric Centre of Excellence University Teaching Hospital Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/08/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independence Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independence Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/12/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independence Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/09/2021 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/01/2022 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/09/2021 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Pediatric Centre of Excellence University Teaching Hospital Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/12/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independence Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/01/2022 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/09/2021 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/12/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independence Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/09/2021 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Pediatric Center of Excellence University Teaching Hospital Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/07/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independence Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/12/2021 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independence Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/04/2022 University of Stellenbosch Health Research Ethics
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2022 Sefako Makgatho University Research Ethics Committee SMUREC Health Science University Mototlegi Street Ga Rankuwa P
Ethics Committee Address
Street address City Postal code Country
Sefako Makgatho Health Science University Mototlegi Street Ga Rankuwa Pretoria Gauteng Pretoria 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/05/2021 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
20 Cambridge Road Harare 7010 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2021 Joint Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Joint Research Ethics Committee C/O University of Zimbabwe College of Health Sciences.Mazowe Road Harare Zimbabwe Harare 0000 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/06/2021 University of California San Francisco Human Research Protection Program Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
490 Illinois Street, Floor 6 San Francisco 94143 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/05/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda P.O Box 6884 Kampala Uganda Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/05/2022 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office Kampala P.O.Box 23096, Kampala, Uganda Plot 19 Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/05/2022 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office Kampala P.O.Box 23096, Uganda, Plot 19, Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/05/2022 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office, Kampala, P.O.Box 23096, Kampala, Uganda Plot 19, Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda P.O.Box 6884 Kampala Uganda Kampala N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/03/2022 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office UKZN Mazisi Kunene Road, Glenwood Durban South Africa Durban 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/05/2022 UCT Health Science Research Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/05/2022 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/05/2022 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/05/2022 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2022 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/05/2021 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Campus Road Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/05/2022 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Paediatric Centre for Excellence Lusaka 0000 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2022 Pharmacy and Medicines Regulatory Authority off Paul Kagame Chilambula Road Lilongwe Malawi
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/06/2022 John Hopkins University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
615 N Wolfe Street Room E1101 Baltimore Maryland Baltimore 21211 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/06/2022 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Indepemdance Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2022 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C O Ministry of Health Research Unit Blantyre 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/06/2022 Walter Reed Army Institute of Research
Ethics Committee Address
Street address City Postal code Country
503 Robert Grant Avenue, Silver Spring Silver Springs 20910 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/06/2022 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
House No 7 KENRI Headquarters P.O.Box 54840 0200 Off Mbagathi Nairobi NONE Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/06/2022 Moi University Teaching and Referral Hospital Moi University College of Health Sciences Institutional Review and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Moi University Teaching and Referral Hospital Building 2nd Floor, Door 219. P.O.Box 3 - 30100, Eldoret Kenya Eldoret 3900-3010 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/06/2022 Moi University Teaching and Referral Hospital Moi University College of Health Sciences Institutional and Review Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Moi University Teaching and Referral Hospital Building, 2nd Floor, Door 219, P.O.Box 3 - 30100, Eldoret Kenya Eldoret 3900-3010 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/12/2021 Moi University Teaching and Referral Hospital Moi University College of Health Sciences Institutional Review and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Moi University Teaching and Referral Hospital Building 2nd floor, Door 219, P.O.Box 3 - 30100, Eldoret Kenya Eldoret 3900-3010 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/07/2022 Kenya Pharmacy and Poison Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi P. O. Box 27663 00506 Nairobi 27663 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/07/2022 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi P.O.Box 27663 00506 Nairobi 27663 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/07/2022 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Campus Road Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/06/2022 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Campus Road Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/07/2021 University of North Carolina at Chapel Hill Biomedical IRB
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King Blvd North Carolina 27599-709 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/06/2022 Pharmacy and Medicines Regulatory
Ethics Committee Address
Street address City Postal code Country
Off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/07/2022 Pharmacy and Medicines Regulatory
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/05/2021 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/07/2022 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Phamacy and Poisons Board House Lenana Road Nairobi P.O.Box 27663 00506 Nairobi Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/07/2022 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Niarobi P.O.Box 27663 00506 Nairobi Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/07/2022 Eswatini Health and Human Research Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Mbandzeni House, 3rd floor, Mbabane, Eswatini Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2022 Columbia University IRB
Ethics Committee Address
Street address City Postal code Country
154 Haven Road First Floor 615 West 131st Street 3rd Floor New York 10032 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/07/2022 Ministry of Health Medicines Regulatory Unit
Ethics Committee Address
Street address City Postal code Country
P. O. Box 5 Mbabane Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/09/2022 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Zambia Medicines Regulatory Authority Plot No. 2350/M P.O. Box 31890 Lusaka Zambia Lusaka N/A Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/09/2022 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Campus Road Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/10/2022 South African Health Products Research Authority
Ethics Committee Address
Street address City Postal code Country
Building A Loftus Park, 402 Kirkness Street, Arcadia Pretoria 0001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/09/2022 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, Senate House, University of the Witwatersrand,1 Jan Smuts Avenue, Braamfontein Johannesburg 2000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/09/2021 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
National Biosafety Authority off Kafue Road Mount Makulu Chilanga Lusaka Zambia Lusaka N/A Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/10/2022 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Paediatric Center for Excellence Lusaka 0000 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2022 University of KwaZulu Natal Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
BREC, Research Office, UKZN, Research Office, Govan Mbeki, Center, Westville, Campus, Durban Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2022 University of Kwazulu Natal Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
BREC, Research Office, UKZN, Research Office, Govan Mbeki, Center Westville, Campus, Durban South Africa Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2022 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room G50 Old,Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2022 UCT HREC University of Cape Town Human Research Ethics Committees
Ethics Committee Address
Street address City Postal code Country
Room G50 Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2022 UCT Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room G50 Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2022 UCT University of Cape Town Human Research Ethics Comiitee
Ethics Committee Address
Street address City Postal code Country
Room G50, Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/11/2022 SAMRC HREC South African Medical Research Council Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Parowvallei 7505 Cape Town South Africa Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2022 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbgathi Road, Nairobi Kenya, House Number 8, KEMRI Headquarters Kisumu 54840 002 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2022 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road Lyttelton Manor Centurion Pretoria South Africa Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2022 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Government Enclave Plot No. 54609 Gaborone Botswana Gaborone 0038 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2022 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi Nairobi 276630050 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2022 Botswana Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park Gaborone Botswana Gaborone 0000 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/11/2022 Harvard Institutional Review Board IRB
Ethics Committee Address
Street address City Postal code Country
90 Smith Street 3rd Floor Boston 02120 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2022 Centre for Disease Control and Prevention
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Road Atlanta GA 30329-4027 Atlanta 30329 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/08/2021 Centre for Disease Control and Prevention
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Road Atlanta GA 30329-4027 Atlanta 30329 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2021 Centre for Disease Control and Prevention
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Road Atlanta GA 30329-4027 Atlanta 30329 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/02/2022 Centre for Disease Control and Prevention
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Road Atlanta GA 30329-4027 Atlanta 30329 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2022 Uganda Virus Research Institute
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute CRS Plot 51-59 Nakiwogo Road Entebbe Uganda Entebbe 49 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Rd, Kampala Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2022 Uganda Virus Research Institute Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute CRS Plot 51-59 Nakiwogo Road Entebbe Uganda Entebbe 49 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Kampala Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2022 Moi University Teaching and Referral Hospital Moi University College of Health Sciences Institutional and Review Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Moi University Teaching and Referral Hospital Building, 2nd Floor, Door 219, P.O.Box 3 - 30100, Eldoret Kenya Eldoret 3900-3010 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2022 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi P.O.Box 27663 00506 Nairobi Nairobi 00506 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/11/2022 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi 27663 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2022 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office Kampala P.O.Box 23096 Kampala Uganda Plot 19 Lumumba Ave Kampala 23096 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2022 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Avenue Kampala Uganda Kampala 23096 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/12/2022 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Avenue Kampala Uganda Kampala 23096 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road, Kampala Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2022 Uganda Virus Research Institute Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute , Plot 51-59, Nakiwogo Road, Entebbe Uganda Entebbe 49 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/11/2022 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
National Drug Authority Plot 19 Lumumba Ave Kampala Uganda Kampala 23096 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2022 Uganda Virus Research Institute Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Uganda Virus Research Institute, Plot 51-59, Nakiwogo Road, Entebbe Uganda Entebbe 49 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/10/2022 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Kampala Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/11/2022 University of North Carolina at Chapel Hill Biomedical IRB
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King Jr. Boulevard North Carolina 27599-709 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/12/2022 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/12/2022 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/12/2022 Ministry of Health Medicines Regulatory Unit
Ethics Committee Address
Street address City Postal code Country
P.O, Box 5 Mbabane Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/07/2021 Ministry of Health Medicines Regulatory Unit
Ethics Committee Address
Street address City Postal code Country
P. O. Box 5 Mbabane Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/11/2021 Ministry of Health Medicines Regulatory Unit
Ethics Committee Address
Street address City Postal code Country
P. O. Box 5 Mbabane Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/03/2022 Ministry of Health Medicines Regulatory Unit
Ethics Committee Address
Street address City Postal code Country
P. O. Box 5 Mbabane Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/12/2022 Columbia University IRB
Ethics Committee Address
Street address City Postal code Country
154 Haven Road First Floor 615 West 131st Street Third Floor New York 10032 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/12/2022 Eswatini Health and Human Research Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Mbadzeni House, 3rd Floor, Mbabane, Eswatini Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/01/2023 John Hopkins Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
615 N. Wolfe Street / Room E1100 Baltimore, Maryland 21205-2179 Baltimore 21211 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/12/2022 Sefako Makgatho University Research Ethics Committee SMU REC
Ethics Committee Address
Street address City Postal code Country
Sefako Makgatho Health Sciences University Molotlegi Street, Ga-Rankuwa Pretoria, Gauteng Pretoria 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/07/2022 Walter Reed Army Institute of Research
Ethics Committee Address
Street address City Postal code Country
503 Robert Grant Avenue, Silver Spring Silver Springs 20910 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/01/2023 Walter Reed Army Institute of Research
Ethics Committee Address
Street address City Postal code Country
503 Robert Grant Avenue, Silver Springs Silver Springs 20910 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/01/2023 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/01/2023 Pharmacy and Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe 30241 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/12/2022 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Road Campus Lusaka 44370 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/01/2023 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot No 2350/M P.O.Box 31890 Lusaka Zambia Lusaka N/A Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/12/2022 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Paediatric Centre of Excellence, University Teaching Office, Off Kasama Road Lusaka 30075 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/01/2023 Pharmacy and Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe 30241 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/03/2023 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, Senate House, University of the Witwatersrand, 1 Jan Smuts Avenue, Braamfontein Johannesburg 2000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/03/2023 University of Stellenbosch Health Research Ethics
Ethics Committee Address
Street address City Postal code Country
Health Research Office Stellenbosch University Tygerberg Campus Research Development and Support Division Room 5008A Stellenbosch Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/03/2023 Harvard Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
90 Smith Street 3rd Floor Boston 021210 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2023 UCT Health Science Faculty Research Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2023 University of Cape Town Human Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/03/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2023 Uganda Virus Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 51 to 59, Nakiwogo Road, Entebbe, Uganda Entebbe NONE Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/03/2023 Uganda Virus Institute Ethics Committee UVRI
Ethics Committee Address
Street address City Postal code Country
Plot 51 -59, Nakiwogo Road, Entebbe, Uganda Entebbe NONE Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/03/2023 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office UKZN Mazisi Kunene Road Glenwood Durban South Africa Durban 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/03/2023 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/0 Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/03/2023 University of KwaZulu Natal Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
BREC, Research Office, UKZN, Govan Mbeki Centre, Westville Campus, Durban, South Africa Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2023 Uganda Virus Institute Ethics Committee UVRI
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 , Nakiwogo Road, Entebbe, Uganda Entebbe None Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/04/2023 South African Medical Research Council Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Parowvallei 7505 Cape Town Sou Cape Town 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2023 University of Stellenbosch Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7502 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2023 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road, Lyttleton Manor, Centurion, Pretoria, South Africa Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Uganda National Council for Science and Technology Plot 6 Nimera Road Ntinda Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/04/2023 Eswatini Health and Human Research Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Mbadzeni House, 3rd Floor, Mbabane, Eswatini Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/04/2023 Columbia University IRB
Ethics Committee Address
Street address City Postal code Country
154 Haven Road First Floor 615 West Street 131st Street Third Floor New York 10032 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2023 KEMRI Scientific and Ethics Review Unit P.O.Box 54840 0200 Off Mbagathi
Ethics Committee Address
Street address City Postal code Country
House No. 7 KEMRI Headquarters P.O.Box 54840 0200 Off Mbagathi Nairobi NONE Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/04/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secratariat Office Kampala P.O.Box 23096, Kampala, Uganda, Plot 19, Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/04/2023 Sefako Makgatho University Research Ethics Committee SMU REC
Ethics Committee Address
Street address City Postal code Country
Sefako Makgatho Health Sciences University Mototlegi Street, Ga-Rankuwa, Pretoria Gauteng Pretoria 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/04/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/04/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office Kampala P.O.Box 23096, Kampala, Uganda Plot 19 Lumumba Ave Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/04/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/05/2023 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/05/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office Kampala, P.O.Box 23096, Kampala Uganda Plot 19 Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/04/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office Kampala P. O. Box 23096, Kampala Uganda Plot 19 Lumumba Avenue Kampala 0000 United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2023 Uganda Virus Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road, Entebbe, Uganda Entebbe NONE Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/05/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2023 Centre for Disease Control and Prevention
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Road Atlanta GA 30329-4027 Atlanta 30329 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2023 University of North Carolina at Chapel Hill Biomedical IRB
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King Jr. Boulevard North Carolina 27599-709 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2023 Ministry of Health Medicines Regulatory Unit
Ethics Committee Address
Street address City Postal code Country
P. O. Box 5, Mbabane Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/05/2023 Pharmacy and Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority Off Paul Kagame Chilambula Road, Lilongwe, Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/05/2023 Pharmacy and Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority Off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/03/2023 South African Health Products Research Authority
Ethics Committee Address
Street address City Postal code Country
Building A Loftus Park, 402 Kirkness Street, Arcadia Pretoria 0001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/05/2023 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Government Enclave Plot No. 54609 Gaborone Botswana Gaborone CRS 0038 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/05/2023 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Kenya Pharmacy and Poisons Board Lenana Road Nairobi P.O.Box 27663 00506 Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/05/2023 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Kenya Pharmacy and Poisons Board House Lenana Road Nairobi P.O.Box 27663 00506 Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/05/2023 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi P.O.Box 27663 00506 Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/06/2023 Botswana Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park Gaborone Botswana Gaborone 0000 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/06/2023 John Hopkins University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
615 N. Wolfe Street / Room E1100, Baltimore, Maryland 21205-2179 Baltimore 21211 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/05/2023 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Road Campus Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2023 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/06/2023 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Paediatric Centre of Excellence, University Teaching Office, Kasama Road Lusaka 30075 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/06/2023 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot No 2350/M P.O.Box 31890 Lusaka Zambia Lusaka N/A Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2023 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/07/2023 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, Senate House, University of the Witwatersrand, 1 Jan Smuts Ave, Braamfontein Johannesburg 2000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/07/2023 Walter Reed Army Institute of Research
Ethics Committee Address
Street address City Postal code Country
503 Robert Grant Avenue, Silver Springs Silver Springs 20910 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/07/2023 Uganda Virus Research Ethics Committee UVRI
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 , Nakiwogo Road, Entebbe, Uganda Entebbe None Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2023 Harvard Institutional Review Board IRB
Ethics Committee Address
Street address City Postal code Country
90 Smith Street 3rd Floor Boston 021210 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/07/2023 University of North Carolina at Chapel Hill Biomedical IRB
Ethics Committee Address
Street address City Postal code Country
720 Martin Luther King Jr. Boulevard North Carolina 27599-709 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/07/2023 South African Health Products Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Building A, Loftus Park, 402 Kirkness Street, Arcadia Pretoria 0001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/07/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/08/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/08/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/07/2023 Columbia University IRB
Ethics Committee Address
Street address City Postal code Country
154 Haven Road First Floor 615 West Street 131st Street Third Floor New York 10032 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/08/2023 John Hopkins University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
615 N Wolfe Street /Room EE1100, Baltimore, Maryland 21205-2179 Baltimore 21211 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/07/2023 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
UCT Health Science Faculty Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/08/2023 Uganda Virus Research Institute HREC
Ethics Committee Address
Street address City Postal code Country
Plot 51-59 Nakiwogo Road, Entebbe, Uganda Entebbe N/A Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2023 University of Stellebosch Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive Cape Town 7502 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/08/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/08/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office, Kampala, P.O. Box 23096, Uganda Plot 19, Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2023 UKZN Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, UKZN, Mazisi Kunene Road, Glenwood Durban, South Africa Durban 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/08/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office, Kampala, P.O.Box 23096, Uganda Plot 19, Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2023 Uganda Virus Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 51-59, Nakiwogo Road, Entebbe, Uganda Entebbe None Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/08/2023 Sefako Makgatho Health Science University SMUREC
Ethics Committee Address
Street address City Postal code Country
Sefako Makgatho Health Science University Mototlegi Street GaRankuwa Pretoria Gauteng Pretoria 4001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/08/2023 Eswatini Health Human and Research Review Board
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Mbadzeni House, 3rd Floor, Mbabane, Eswatini Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/07/2023 Ministry of Health Medicines Regulatory Unit
Ethics Committee Address
Street address City Postal code Country
P.O. Box 5, Mbabane Mbabane H100 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/08/2023 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road, Lyttleton Manor, Centurion, Pretoria, South Africa Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/08/2023 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O/ Ministry of Health Research Unit Blantyre 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/08/2023 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O/ Ministry of Health Research Unit Lilongwe 30377 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/08/2023 Uganda Virus Research Institute Ethics
Ethics Committee Address
Street address City Postal code Country
Plot 51059, Nakiwogo Road Entebbe 31405 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/08/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office Kampala, P.O. Box 23096, Uganda, Plot 19, Lumumba Avenue Kamoala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/08/2023 Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Government Enclave Plot No. 54609 Gaborone Botswana Gaborone CRS 0038 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/08/2023 SAMRC HREC South African Medical Research Council Human Research Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
Francie van Zuyl Drive, Parowvallei, 7505, Cape Town Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/09/2023 Botswana Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park Gaborone Botswana Gaborone 0000 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/08/2023 Botswana Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 112 International Finance Park Gaborone Botswana Gaborone 0000 Botswana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/09/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda Kampala, Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/08/2023 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Secretariat Office, Kampala, P.O.Box 23096, Uganda, Plot 19. Lumumba Avenue Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2023 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda Kampala Uganda Kampala 0000 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2023 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Kenya Pharmacy and Poisons Board Lenana Road Nairobi P.O.Box 27663 00506 Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/08/2023 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Great East Road Campus, Ridgeway Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/07/2023 Moi University Teaching and Referral Hospital Moi University College of Health Sciences Institutional and Review Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Moi University Teaching and Referral Hospital Building, 2nd Floor, Door 219, P.O.Box 3 to 30100, Eldoret, Kenya Eldoret 3900-3010 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2023 Pharmacy and Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority Off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/09/2023 Centre for Disease Control and Prevention
Ethics Committee Address
Street address City Postal code Country
1600 Clifton Road, Atlanta, GA, 30329-4027 Atlanta 30329 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2023 Pharmacy and Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Medicines Regulatory Authority Off Paul Kagame Chilambula Road Lilongwe Malawi Lilongwe N/A Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/09/2023 National Health Research Authority
Ethics Committee Address
Street address City Postal code Country
Paediatric Centre of Excellence University Teaching Hospital Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2023 National Biosafety Authority
Ethics Committee Address
Street address City Postal code Country
Off Kafue Road Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/10/2023 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi P.O.Box 27663 Nairobi N/A Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/09/2023 Kenya Pharmacy and Poisons Board
Ethics Committee Address
Street address City Postal code Country
Pharmacy and Poisons Board House Lenana Road Nairobi 27663 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/10/2023 Walter Reed Army Institute of Research
Ethics Committee Address
Street address City Postal code Country
503 Robert Grant Avenue, Silver Springs Silver Springs 20910 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/09/2023 Zambia Medicines Regulatory Authority
Ethics Committee Address
Street address City Postal code Country
Plot 348 Independance Road Woodlands Lusaka 10101 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/09/2021 National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
C/O Ministry of Health Research Unit Lilongwe 30377 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PRE-MONTH 6 STAGE: to assess the relative risk of symptomatic COVID-19 in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) who receive a 2-dose mRNA-1273 vaccine regimen in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose PRE-MONTH 6 STAGE: to assess the relative risk of severe COVID-19 in Group 1 (PLWH who are SARSCoV-2 negative at baseline) who receive a 2-dose mRNA1273 vaccine regimen in Group 2 (PLWH who are SARS-CoV-2 positive at baseline) who receive a 1-dose mRNA-1273 regimen, counting endpoints starting 1 day after Month 0 dose until Month 6 dose. POST-MONTH 6 STAGE: to assess the relative risk of symptomatic COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. POST-MONTH 6 STAGE: to assess the relative risk of severe COVID-19 after the Month 6 dose among those who received mRNA-1273 at Month 6 those who received mRNA-1273.222 at Month 6, counting endpoints at least 14 days after the Month 6 dose until end of follow up. To assess the safety and tolerability of mRNA-1273 and mRNA-1273.222 in adults who are at risk of severe COVID-19 in both the pre-Month 6 and post-Month 6 stages. Endpoints and end of trial
Secondary Outcome PRE-MONTH 6 & POST-MONTH 6 STAGES: to assess the relative risk of asymptomatic SARS-CoV-2 infection defined by nucleocapsid protein seroconversion after the Month 6 dose in Group 1 (PLWH who are SARS-CoV-2 negative at baseline) and in Group 3 (people HIV-negative who are SARS-CoV-2 negative at baseline) combined, among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints starting 1 day after dose 1, 14 days after the last dose before Month 6 dose, or 14 days after Month 6 dose until the end of follow up PRE-MONTH 6 & POST-MONTH 6 STAGES: to assess the relative risk of symptomatic COVID-19, and severe COVID-19 after the Month 6 dose in Groups 1 and 3 together (participants who are SARS-CoV-2 negative at baseline regardless of HIV status) and in Groups 2 and 4 together (participants who are SARS-CoV-2 positive at baseline regardless of HIV status), respectively, among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6, counting endpoints starting 1 day after dose 1 or 14 days after the last dose before Month 6 dose until the end of follow up. SARS-CoV-2 viral load (as inferred from RT-PCR cycle threshold values) and viral whole genome sequences . To assess post-vaccination immune response markers and immune markers as correlates of risk of COVID-19 and as correlates of protection against COVID-19 in all study groups together. Endpoints and End of Trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Desmond Tutu Health Foundation Clinical Trials Unit J52 Old Main Building, J Floor, Groote Schuur Hospital, Main Road, Observatory, Cape Town 7925 South Africa
Josha Research CRS 28 East Burger Street, Bloemfontein, South Africa Bloemfontein 9300 South Africa
Emavundleni CRS 14 Sonwabile Drive, Old Crossroads, Klipfontein AND, Hob 38 -Ground Floor, Philippi Crescent, Philippi, 7781 Cape Town 7750 South Africa
Desmond Tutu Health Foundation Clinical Trials Unit J52 Old Main Building, J Floor, Groote Schuur Hospital, Main Road, Observatory, Cape Town 7925 South Africa
TASK Central TASK Applied Science, Central 1 De Lange Street, Bellville Cape Town 7530 South Africa
University of Cape Town Lung Institute CRS University of Cape Town Lung Institute Pty-Ltd, Centre for Tuberculosis Research Innovation, George Street, Mowbray Cape Town 7700 South Africa
CAPRISA eThekwini CRS No. 3 Richards Road, Warwick Avenue, Berea, KwaZulu-Natal Durban 4001 South Africa
Isipingo CRS South African Medical Research Council, HIV Prevention Research Unit, 3-13 Police Station Road lsipingo Rail, Kwa-Zulu Natal Isipingo Durban 4110 South Africa
Tongaat CRS South African Medical Research Council, HIV Prevention Research Unit, 12-14 Tesco Drive, KwaZulu Natal Tongaat Durban 4400 South Africa
Synergy Biomed Research Institute SBRI Synergy Biomed Research Institute, Suite 3 Tudor Court, 280 Oxford Street East London 5241 South Africa
Ndlovu Research Center Ndlovu Research Centre, Plot 1140, Elandsdoorn, Limpopo Dennilton 0470 South Africa
TASK Eden 4 Victoria Street, George, Eastern Cape George 6529 South Africa
Phoenix Pharma 2 Eastbourne Road, Mount Croix Port Elizabeth Eastern Cape South Africa Port Elizabeth 6001 South Africa
Clinical HIV Research Unit CHRU Helen Joseph CRS University of Witwatersrand Clinical HIV Research Unit Themba Lethu Clinic Helen Joseph Hospital Perth Road Westdene Johannesburg 2000 South Africa
Wits RHI Ward 21 CRS Wits RHI Ward 21 CRS Hillbrow Health Precinct 22 Esselen Street Hillbrow Johannesburg 2000 South Africa
Newtown Clinical Research Newtown Clinical Research Centre First Floor Newgate Centre 104 Rahima Moosa -Jeppe Street Newtown Johannesburg 2001 South Africa
MERC Kempton Shop 53A, Kempton Square Cnr Voortrekker and Monument Rd Kempton Park Gauteng, South Africa Kempton Park 1619 South Africa
Aurum Institute Klerksdorp CRS The Aurum Institute CRS Gavin J Churchyard Legacy Centre Klerksdorp Clinical Research Centre 201 Jade Square Centre Klerskdorp 2571 South Africa
PHRU Matlosana CRS Tshepong Hospital MDR Unit 54 Benji Olifant Street Jouberton Klerksdorp Northwest South Africa Klerskdorp 2574 South Africa
Qhakaza Mbokodo Research Clinic CRS 15 Parklane Mkhamba Gardens Ladysmith Kwa-Zulu Natal South Africa Ladysmith 3370 South Africa
Synexus Stanza Clinical Research Centre CRS 02 Shilovhane Street Mamelodi East Pretoria Gauteng South Africa Pretoria 0122 South Africa
Masiphumelele Clinical Research Site MASI CRS Guinea Fowl Road Sunnydale Cape Town Cape Town 7975 South Africa
Mecru Clinical Research Unit Sefako Makgatho Health Science University Medunsa South Africa. Pretoria 0204 South Africa
MERC Middelburg MERC Middelburg, 184 Cowen Ntuli Road Middelburg South Africa Middelburg 1055 South Africa
Nelson Mandela Academic Research Unit CRS Nelson Mandela Academic Clinical Research Unit -NeMACRU Sir Henry Elliot Hospital 17 Hospital Road Mthatha Eastern Cape Mthatha 5099 South Africa
Rustenburg CRS First Floor 50 Steen Street Cnr Pretorius Street Rustenburg North West South Africa Rustenburg 0299 South Africa
Synexus Helderberg Synexus Helderberg Clinical Research Centre Suite 7G and H Arun Place Sir Lawry s Pass Road Somerset West South Africa Somerset West 7130 South Africa
Soweto Bara CRS Perinatal HIV Research Unit Bara Chris Hani Baragwanath Academic Hospital Chris Hani Road Diepkloof Soweto Johannesburg Johannesburg 1864 South Africa
Soweto Kliptown CRS Perinatal HIV Research Unit Kliptown Office no 7 Walter Sisulu Square Cnr Union and Klipspruit Valley Roads Kliptown Soweto Johannesburg 1809 Johannesburg 1809 South Africa
Tembisa Clinic 4 Cnr Rev RTJ Namane and Flint Mazibuko Drive Hospital View, Tembisa Gauteng South Africa Tembisa 1632 South Africa
FAMCRU Family Clinical research Unit University of Stellenbosch Paediatric Infectious Diseases Clinical Research Unit Ward J8 Tygerberg Academic Hospital Francie van Zijl Drive Parow Valley Cape Town Parow Cape Town 7505 South Africa
FAMCRU Family Clinical research Unit Worcester Campus 1 Sugget Street, Worcester, 6850 Ukwanda Centre Worcester Campus 1 Durban Road Worcester Worcester 6850 South Africa
CAPRISA Vulindlela CRS adjacent to Mafakatini Primary Healthcare Clinic Road P402 Ward 9 UMgungundlovu District Durban KwaZulu Natal South Africa Durban 4002 South Africa
MERC Welkom MERC Welkom 189 Power Road Welkom South Africa Welkom 9460 South Africa
Gaborone CRS Extension 9 Plot 2730, Hospital Way, Botswana Gaborone 61101 Botswana
Eswatini Prevention Center CRS Smuts Street, behind Mona Flats, P.O. Box 222 Eveni H103, Mbabane, Eswatini Mbabane H100 Swaziland
Kisumu CRS Jaramogi Oginga Odinga Teaching and Referral Hosp., Off Kakamega Road P.O. Box 1578, Nyanza, Kenya Kisumu 40100 Kenya
Eldoret Moi University CRC Chandaria Cancer and Chronic Diseases Centre - CCCDC at Moi Teaching and Referral Hospital -MTRH, Nandi Road, PO Box 4606, Eldoret, Rift Valley, Kenya Eldoret 30100 Kenya
Blantyre CRS Johns Hopkins Research Project, Queen Elizabeth Central Hospital, Chipatala Avenue, P.O. Box 1131, Malawi Blantyre 312200 Malawi
Malawi CRS Lilongwe UNC Project, Tidziwe Centre, 100 Mzimba Road, Kamuzu Central Hospital, Private Bag A-104, Malawi Lilongwe 1207201 Malawi
Entebbe URVI IAVI CRS Plot 51-59 Nakiwogo Road , PO Box 49, Entebbe, Uganda Entebbe 31405 Uganda
Kampala Baylor Uganda CRS Block 5 Mulago Hospital, PO Box 72052, Uganda Kampala 10102 Uganda
Joint CRC JCRC Joint Clinical Research Centre, Plot 101, Lubowa Estates, off Entebbe Road, PO Box 10005, Kampala, Uganda Kampala 10102 Uganda
Kampala MUJU Research Collaboration MUJHU CARE LTD, Upper Mulago Hill Road, PO Box 23491, Kampala, Uganda Kampala 10102 Uganda
Lusaka UNC UNC Global Projects / Kamwala District Health Centre Lusaka 50100 Zambia
Zambia Emory HIV Research Project Ndola CRS 24 Lupili Road, Northrise, Ndola Ndola 10101 Zambia
Matero Reference Clinic CRS Matero 1st Level Hospital, Chitimukulu Road, Matero, Lusaka, Lusaka, Zambia Lusaka 10101 Zambia
Kombewa CRS Off Kisumu-Bondo Road, Opposite Kombewa County Hospital Kisumu 54-40100 Kenya
Kombewa CRS Off Kisumu-Bondo Road, Opposite Kombewa County Hospital P. O. Box 54-40100 Kisumu, Kenya Alternate thru embassy Kisumu Unit 8900 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NIAID NIAID -5601 Fishers Lane MSC 9806 Bethesda MD 20892-9806 United States of America BETHESDA 20892-980 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SOUTH AFRICAN MEDICAL RESEARCH COUNCIL SAMRC SAMRC, Francie Van Zijl Road, Parow Valley, PO Box 19070, Tygerberg Cape Town 7505 South Africa Medical Research Institution
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nigel Garrett Nigel.Garrett@caprisa.org +27763308300 CAPRISA eThekwini CRS, Centre for the AIDS Programme of Research in South Africa
City Postal code Country Position/Affiliation
Durban 4013 South Africa Protocol Chair
Role Name Email Phone Street address
Principal Investigator Philip Kotze plkotze@gmail.com +2700000000 Ladysmith CRS, Qhakaza Mbokodo Research Clinic
City Postal code Country Position/Affiliation
Ladysmith 3370 South Africa Protocol Chair
Role Name Email Phone Street address
Scientific Enquiries Nigel Garrett nigel.garrett@caprisa.org +27316550617 Centre for the AIDS Programme Of Research in South Africa -CAPRISA, Nelson R Mandela School of Medicine, UKZN, Private Bag X7, Congella
City Postal code Country Position/Affiliation
Durban 4013 South Africa Protocol co chair
Role Name Email Phone Street address
Scientific Enquiries Philip Kotze plkotze@gmail.com +27366312372 15 Parklane, Mkhamba Gardens, Ladysmith, Kwa-Zulu Natal, South Africa
City Postal code Country Position/Affiliation
Ladysmith 3370 South Africa Protocol co chair
Role Name Email Phone Street address
Public Enquiries Glenda Gray glenda.gray@mrc.ac.za +27123398524 South African Medical Research Council -SAMRC, Francie van Zijl Drive, Parowvallei, Tygerberg
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Sponsor representative
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The results of the trial will be shared with trial participant in a manner clearly stipulated by the protocol team. The Study Report will also be made available in line with the country, international and sponsor regulations. Clinical Study Report 3 years Final Study Report from protocol team
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information