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: www.pactr.org
Trial no.: PACTR202102855526180 Date of Approval: 15/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sisonke (Together): OPEN LABEL TRIAL Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa (VAC31518COV3012
Official scientific title Sisonke (Together): OPEN LABEL TRIAL Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa (VAC31518COV3012
Brief summary describing the background and objectives of the trial Title - To monitor the effectiveness of the single shot Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa Design - Open-label, single-arm phase 3B vaccine implementation study Rationale: South Africa is severely affected by the global COVID-19 epidemic, but currently no vaccine has been rolled out. The recent promising results of the ENSEMBLE trial conducted by Janssen in South Africa, and the availability of a limited amount of vaccine doses, provide the rationale for a cohort study of vaccinated HCWs to inform the larger vaccine rollout. Population- Health Care workers age 18 and above working in the South African public and private health care sector (N=500 000) Sites - Department of Health Vaccine administration sites across South Africa supported by the Ensemble trial Research Site Investigators and Study Staff Duration - Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination. A sub-group will be followed up for 6 months. Study Product - Ad26.COV2.S by Janssen administered as a single injection Primary Objective - To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID, hospitalizations and deaths in HCWs Secondary Objective - To estimate the incidence of symptomatic SARS CoV-2 infections in HCW To estimate vaccine uptake among HCWs in South Africa To monitor the genetic diversity of breakthrough SARS CoV-2 infections In a subgroup of participants: To compare serum neutralization and immune responses before and after vaccination To monitor for asymptomatic infection To establish a link between the national pharmacovigilance system to assist with monitoring safety and any unexpected adverse effects
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SisonkeTogether
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 01/03/2021
Actual trial start date 17/02/2021
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 500000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://www.samrc.ac.za/
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ad26 COV2S by Janssen administered as a single injection Ad26 COV2S by Janssen administered as a single injection Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination. A sub-group will be followed up for 6 months Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination. A sub-group will be followed up for 6 month 500000
Control Group Not applicable Not applicable Not applicable Not applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria Age 18 and older Health care worker in the private or public service The President and Deputy President of South africa (*The President and Deputy President of South Africa have been included in the protocol to address the issue of vaccine hesitancy.) Willingness and ability to comply vaccination plan and other study procedures. Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol. Inclusion criteria for the sub-cohort Age 18 and older Health care worker in the private or public service Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures, with follow-up at an ENSEMBLE site. Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol. Exclusion criteria Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant Known pregnancy Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. Immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the stud 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 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 11/02/2021 Sefako Makgatho University Research Ethics Committee SMUREC
Ethics Committee Address
Street address City Postal code Country
Molotlegi Street Ga-Rankuwa, Pretoria, Gauteng 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 12/02/2021 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl 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 12/02/2021 University of Kwa Zulu Natal Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
The University Research Office, Govan Mbeki building, Westville campus UKZN Durban 3629 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 15/02/2021 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
I Jan smuts Avenue, Braamfontein, Johannesburg 2001 Johannesburg 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rates of hospitalizations and deaths among vaccinated HCWs versus general unvaccinated population Rates of hospitalizations and deaths
Secondary Outcome To estimate the incidence of symptomatic SARS CoV-2 infections among vaccinated HCWs To monitor the genetic diversity of breakthrough SARS CoV-2 infections To measure serum neutralization and T-cell responses among vaccinees (estimated sub-set of 10,000) To monitor for asymptomatic infection in a sub-set of HCWs To conduct pharmacovigilance to monitor for safety and any unexpected adverse effects of the vaccine administration To estimate vaccine uptake among HCWs in South Africa Incidence rate of SARS CoV-2 infection as indicated by self-report and validation in national laboratory records. Rates of severe disease in HCW who are found to be RT-PCR positive at up to 2 years po
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
PHOENIX Pharma Pty Ltd PHOENIX Pharma Pty Ltd Port Elizabeth 6001 South Africa
Desmond Tutu Health Foundation CTU J52 Old Main Building 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
TASK Clinical Research Centre 1 Smal Street Belville Cape Town 7530 South Africa
TASK Applied Science Nquabelani Road and Umbashe Street, Ext 6, Mfuleni Cape Town 7100 South Africa
Perinatal HIV Research Unit Kliptown Office no. 7, Walter Sisulu Square, Corner Union and Klipspruit Valley Roads, Kliptown, Soweto Johannesburg 1809 South Africa
FAMCRU Family Clinical Research Unit University of Stellenbosch, Pediatric Infectious Diseases Clinical Research Unit, Ward J8, Tygerberg Academic Hospital, Francie van Zijl Drive, Parow Valley, South Africa, Cape Town 7505 South Africa
Chatsworth Clinical Research Site South Africa Medical Research Council, HIV Prevention Research Unit, R.K. Khan Circle, Chatsworth, KwaZulu Natal, South Africa, 4030 Durban 4030 South Africa
Josha Research 8 East Burger Street, Bloemfontein, 9300, South Africa Bloemfontein 9300 South Africa
Setshaba Research Centre 2088 Block H, Soshanguve, 0152, South Africa Pretoria 0152 South Africa
The Aurum Institute Tembisa Clinical Research Clinic 4, cnr Rev RTJ Namane and Flint Mazibuko Drive, Hospital View Tembisa 1632 South Africa
Qhakaza Mbokodo Research Clinic 15 Parklane, Mkhamba Gardens, Ladysmith, Kwa-Zulu Natal Ladysmith 3370 South Africa
The Aurum Institute Klerksdorp Clinical Research Centre 201 Jade Square Centre, Cnr Margaretha Prinsloo and OR Tambo Drive Klerksdorp, North West Province, South Africa, 2571 Klerksdorp 2571 South Africa
The Aurum Institute Rustenburg Clinical Research Centre First Floor, 50 Steen Street, Cnr Pretorius Street, Rustenburg, North West, Rustenberg 0299 South Africa
Emavundleni Research Centre 14 Sonwabile Drive, Old Crossroads, Klipfontein, 7750, Cape Town, South Africa Cape Town 7750 South Africa
Synexus SA Stanza Clinical Research Centre 02 Shilovhane street, Mamelodi East Pretoria 0122 South Africa
Themba Lethu HIV Research Unit CHRU Helen Joseph Hospital, Perth Road, Westdene, Johannesburg South Africa Johannesburg 2092 South Africa
CAPRISA eThekwini Clinical Research Site 3 Richards Road, Warwick Avenue, Berea Durban 4001 South Africa
Desmond Tutu Health Foundation Masiphumelele Research Office Guinea Fowl Road, Sunnydale Masiphumelele 7975 South Africa
Perinatal HIV Research Unit PHRU Soweto New Nurses Home, Chris Hani Baragwanath Academic Hospital, Chris Hani Road, Soweto Johannesburg 1862 South Africa
Khayelitsha CRS Site B CHC, 98 Sulani Drive, Khayelitsha Cape Town 7784 South Africa
Tongaat Clinical Research Site South African Medical Research Council, HIV Prevention Research Unit, 12-14 Tesco Drive, Tongaat, KwaZulu Natal Tongaat 4400 South Africa
South African Vaccine Initiative SATVI Project Office, Brewelskloof Hospital Haarlem Street Worcester 6850 South Africa
CAPRISA Vulindlela Clinical Research Site Adjacent to Mafakatini Primary Healthcare Clinic, Road P402, Ward 9, uMgungundlovu District uMgungundlovu District 3201 South Africa
CRISMO Research Centre Bertha Gxowa Hospital, Villa Heidi Building, Joubert and Hospital Street, Germiston Germiston 1401 South Africa
Bothas Hill Clinical Research Site 1 Zulu Road, Valley Trust, Bothas Hill Kwazulu Natal 3660 South Africa
Synexus Helderberg Clinical Research Centre Suite 7G and H Arun Place, Sir Lowrys Pass Road Somerset West 7130 South Africa
Synexus Watermeyer Clinical Research Centre 60 Stamvrug Street, Val de Grace Pretoria 0184 South Africa
Nelson Mandela Academic Clinical Research Unit NeMACRU 17 Hospital Road Mthatha 5100 South Africa
MeCRU Clinical Research Unit Sefako Makgatho Health Sciences University Molotlegi Street Ga-Rankuwa Pretoria 0204 South Africa
Mzansi Ethical Research Centre Middleburg Land Bank Building 186 Cowen Ntuli Street Middelburg Middelburg 1050 South Africa
Ndlovu Research Centre 22 Witstinkhout Street, Globlersdal, 0470 Globersdal 0470 South Africa
Wits RHI Shandukani Research Centre 2nd Floor, Hillbrow Health Precinct Corner Esselen and Klein Street Hillbrow Johannesburg 2001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Francie van Zijl Drive Parowvallei Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical 7505 Council Francie van Zijl Drive Parowvallei Cape town 7505 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
National Institute of Communicable Diseases 1 Modderfontein Road Sandringham Johannesburg 2131 South Africa
National Department of Health of South Africa Civitas Building Cnr Thabo Sehume and Struben Streets Pretoria 0001 South Africa
KwaZulu Natal Research Innovation and Sequencing Platform KRISP K-RITH Tower Building Nelson R Mandela School of Medicine, UKZN 719 Umbilo Road, Durban, South Africa Durban 4001 South Africa
University of the Witwatersrand 1 Jan Smuts Avenue Braamfontein Johannesburg 2001 South Africa
Fred Hutchinson Cancer Research Center 1100 Fairview Ave. N. Seattle WA 98109- United States of America
Hutchinson Centre Research Institute of South Africa Chris Hani Baragwanath Academic Hospital Soweto Johannesburg 2196 South Africa
Bio Analytical Research Corporation South Africa BARC 1st Floor Napier House 11 Napier Road Richmond Johannesburg 2192 South Africa
Dischem Pharmacy Cnr Le Roux and Stag Rd Glen Austin Midrand 1685 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Glenda Gray glenda.gray@mrc.ac.za 0027213398524 Francie van Zijl Drive Parowvallei,
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Co Principal Investigator
Role Name Email Phone Street address
Principal Investigator LindaaGail Bekker linda-gail.bekker@hiv-research.org.za 0027216506970 The Desmond Tutu HIV Centre University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Co Principal Investigator
Role Name Email Phone Street address
Public Enquiries Fatima Mayat mayatf@phru.co.za 00279899798 Perinatal HIV research unit Chris Hani Baragwanath Academic Hospital Soweto
City Postal code Country Position/Affiliation
Johannesburg 1862 South Africa Implementation and Operational Support
Role Name Email Phone Street address
Scientific Enquiries Glenda Gray glenda.gray@mrc.ac.za 0027213398524 SAMRC Francie van Zijl Drive Parowvallei
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Co Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 12 months of the study completion date. Informed Consent Form,Study Protocol 12 months on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
samrc.ac.za 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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 13/02/2021 age category added Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 14/02/2021 Date had been incorrect 13 Feb 2021 30 Sep 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 15/02/2021 edit ENSEMBLE OPEN LABEL Sisonke (Together) ENSEMBLE OPEN LABEL Sisonke (Together) COVID-19
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 15/02/2021 edit ENSEMBLE OPEN LABEL Sisonke (Together) Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single shot Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa ENSEMBLE OPEN LABEL Sisonke (Together). Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single shot Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 15/02/2021 edit Title - To monitor the effectiveness of the single shot Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa Design - Open-label, single-arm phase 3B vaccine implementation study Rationale: South Africa is severely affected by the global COVID-19 epidemic, but currently no vaccine has been rolled out. The recent promising results of the ENSEMBLE trial conducted by Janssen in South Africa, and the availability of a limited amount of vaccine doses, provide the rationale for a cohort study of vaccinated HCWs to inform the larger vaccine rollout. Population- Health Care workers age 18 and above working in the South African public and private health care sector (N=500 000) Sites - Department of Health Vaccine administration sites across South Africa supported by the Ensemble trial Research Site Investigators and Study Staff Duration - Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination. A sub-group will be followed up for 6 months. Study Product - Ad26.COV2.S by Janssen administered as a single injection Primary Objective - To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID, hospitalizations and deaths in HCWs Secondary Objective - To estimate the incidence of symptomatic SARS CoV-2 infections in HCW To estimate vaccine uptake among HCWs in South Africa To monitor the genetic diversity of breakthrough SARS CoV-2 infections In a subgroup of participants: To compare serum neutralization and immune responses before and after vaccination To monitor for asymptomatic infection To establish a link between the national pharmacovigilance system to assist with monitoring safety and any unexpected adverse effects Title - To monitor the effectiveness of the single shot Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa Design - Open-label, single-arm phase 3B vaccine implementation study Rationale: South Africa is severely affected by the global COVID-19 epidemic, but currently no vaccine has been rolled out. The recent promising results of the ENSEMBLE trial conducted by Janssen in South Africa, and the availability of a limited amount of vaccine doses, provide the rationale for a cohort study of vaccinated HCWs to inform the larger vaccine rollout. Population- Health Care workers age 18 and above working in the South African public and private health care sector (N=500 000) Sites - Department of Health Vaccine administration sites across South Africa supported by the Ensemble trial Research Site Investigators and Study Staff Duration - Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination. A sub-group will be followed up for 6 months. Study Product - Ad26.COV2.S by Janssen administered as a single injection Primary Objective - To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID, hospitalizations and deaths in HCWs Secondary Objective - To estimate the incidence of symptomatic SARS CoV-2 infections in HCW To estimate vaccine uptake among HCWs in South Africa To monitor the genetic diversity of breakthrough SARS CoV-2 infections In a subgroup of participants: To compare serum neutralization and immune responses before and after vaccination To monitor for asymptomatic infection To establish a link between the national pharmacovigilance system to assist with monitoring safety and any unexpected adverse effects
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other Infections and Infestation disease 15/02/2021 edit Covid 19 Covid-19
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 06/03/2021 Protocol has been updated ENSEMBLE OPEN LABEL Sisonke (Together) COVID-19 Sisonke (Together): OPEN LABEL TRIAL Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa (VAC31518COV3012
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 06/03/2021 Protocol has been updated ENSEMBLE OPEN LABEL Sisonke (Together). Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single shot Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa Sisonke (Together): OPEN LABEL TRIAL Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa (VAC31518COV3012
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/03/2021 updated 17 Feb 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/03/2021 Protocol has been updated Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 06/03/2021 Protocol has been updated Inclusion criteria Age 18 and older Health care worker in the private or public service Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures. Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol. Inclusion criteria Age 18 and older Health care worker in the private or public service The President and Deputy President of South africa (*The President and Deputy President of South Africa have been included in the protocol to address the issue of vaccine hesitancy.) Willingness and ability to comply vaccination plan and other study procedures. Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol. Inclusion criteria for the sub-cohort Age 18 and older Health care worker in the private or public service Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures, with follow-up at an ENSEMBLE site. Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 06/03/2021 Corrected Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/03/2021 additional ethics approval TRUE, University of the Witwatersrand Human Research Ethics Committee , I Jan smuts Avenue, Braamfontein, Johannesburg 2001, Johannesburg, 2000, South Africa, , 15 Feb 2021, 27112749200, HREC-Medical.ResearchOffice@wits.ac.za, 15686_13085_4737.pdf