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.: PACTR202203582920839 Date of Approval: 14/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Multi-Centre, Randomized, Double Blind, Phase 2b Trial to Evaluate the Safety and Immunogenicity of Janssen Ad26COVS1 and Novavax NVX-CoV2373 COVID-19 vaccines for Homologous and Heterologous Boosting in Adolescents and Adults Aged 12 to 64 Years with and without HIV infection in 3 African Countries (Kenya, Democratic Republic of Congo, and Rwanda).
Official scientific title A Multi-Centre, Randomized, Double Blind, Phase 2b Trial to Evaluate the Safety and Immunogenicity of Janssen Ad26COVS1 and Novavax NVX-CoV2373 COVID-19 vaccines for Homologous and Heterologous Boosting in Adolescents and Adults Aged 12 to 64 Years with and without HIV infection in 3 African Countries (Kenya, Democratic Republic of Congo, and Rwanda).
Brief summary describing the background and objectives of the trial SARS-CoV-2 morbidity and mortality has been catastrophic with greater than 5.54 million deaths and over 328 million confirmed cases worldwide. Africa has more than 7 million cases and 160, 804 thousand deaths as of 17 January 2022. The COVID-19 pandemic has caused global suffering, mortality, and severe economic pressures. Despite the rapid successes in vaccine development and issuance of WHO Emergency Use Listings (EUL), the WHO SAGE Interim Reports and FDA Emergency Use Authorization (EUA) for COVID-19 vaccine evaluations have reported limitations on safety and efficacy data in certain populations including children and adolescents, pregnant women, and immunocompromised individuals such as those with HIV/AIDS who are at higher risk of severe COVID-19 disease. In addition, new waves of COVID-19 cases caused by Variants of Concern (VOC) exacerbate global public health crisis hence need for optimal timing of booster doses for vaccinated populations. The FDA and WHO have both recommended continued evaluation of vaccine effectiveness following issuance of a EUA and/or licensure which is critical to address the existing uncertainties, with high urgency to understand homologous and heterologous boosting, both for improved coverage of variants of concern and due to limitations of global vaccine availability. Based on a recent systematic review and meta-regression analysis, across the four WHO EUL COVID-19 vaccines with the most data (i.e., BNT162b2, mRNA 1273, Ad26.COV2.S and ChAdOx1-S vaccine), vaccine effectiveness against severe COVID-19 decreased by about 8% over a period of 6 months in all age groups. This study will be a multi-centre, randomized, double-blind, phase 2b trial to assess the safety, and immunogenicity of Janssen Ad.26COV2.S1 and Novavax NVX-CoV2373 booster vaccines in adults 18-64 years of age and adolescents 12-17 years of age staggered in 2 stages. There will be a total of about 1,950 participants in 3 sites accross the 3 countries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 2b
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 04/04/2022
Actual trial start date
Anticipated date of last follow up 04/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1950
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Janssen Ad26COVS1 0.5 ml Day 0 Stage 1: In the intevention arm, study participants who are HIV positive adults will be randomized to receive either a single dose of Janssen Ad26COVS1 or Novavax NVX-CoV2373 vaccine at day 0. The participants will be stratified 2:1 by age (18-44; 45-64) within each primary platform ( mRNA, Adenovector and Inactivated vaccine platforms) with a goal of 2:1:1 distribution of adults from Kenya, DRC and Rwanda. The goal will be randomization of approximately 450 adults (expected 2:1 distribution of ages 18-44:45-64) per primary vaccine platform. In the control arm, a group of 300 HIV (-) adult participants (aged 18-64, inclusive) will be enrolled who have received a homologous primary series from one of the three platforms (~100/primary platform). All participants will be randomized 1:1 within their primary vaccine platform to receive a single dose of either Janssen Ad26COVS1 COVID-19 vaccine or Novavax NVX-CoV2373 COVID-19 vaccine between 5 and 7 months from completion of their primary series. 675
Experimental Group Novavax NVX CoV2373 0.5 ml Day 0 Stage 1: In the intevention arm, study participants who are HIV positive adults will be randomized to receive either a single dose of Janssen Ad26COVS1 or Novavax NVX-CoV2373 vaccine at day 0. The participants will be stratified 2:1 by age (18-44; 45-64) within each primary platform ( mRNA, Adenovector and Inactivated vaccine platforms) with a goal of 2:1:1 distribution of adults from Kenya, DRC and Rwanda. The goal will be randomization of approximately 450 adults (expected 2:1 distribution of ages 18-44:45-64) per primary vaccine platform. In the control arm, a group of 300 HIV (-) adult participants (aged 18-64, inclusive) will be enrolled who have received a homologous primary series from one of the three platforms (~100/primary platform). All participants will be randomized 1:1 within their primary vaccine platform to receive a single dose of either Janssen Ad26COVS1 COVID-19 vaccine or Novavax NVX-CoV2373 COVID-19 vaccine between 5 and 7 months from completion of their primary series. 675
Control Group Janssen Ad26COVS1 0.5 ml Day 0 Stage 1: Study participants who are HIV positive adults will be randomized to receive either a single dose of Janssen Ad26COVS1 or Novavax NVX-CoV2373 vaccine at day 0. The participants will be stratified 2:1 by age (18-44; 45-64) within each primary platform ( mRNA, Adenovector and Inactivated vaccine platforms) with a goal of 2:1:1 distribution of adults from Kenya, DRC and Rwanda. The goal will be randomization of approximately 450 adults (expected 2:1 distribution of ages 18-44:45-64) per primary vaccine platform. In the control arm, a group of 300 HIV (-) adult participants (aged 18-64, inclusive) will be enrolled who have received a homologous primary series from one of the three platforms (~100/primary platform). All participants will be randomized 1:1 within their primary vaccine platform to receive a single dose of either Janssen Ad26COVS1 COVID-19 vaccine or Novavax NVX-CoV2373 COVID-19 vaccine between 5 and 7 months from completion of their primary series. 150 Active-Treatment of Control Group
Control Group Novavax NVX CoV2373 O.5 ml Day 0 Stage 1: In the intevention arm, study participants who are HIV positive adults will be randomized to receive either a single dose of Janssen Ad26COVS1 or Novavax NVX-CoV2373 vaccine at day 0. The participants will be stratified 2:1 by age (18-44; 45-64) within each primary platform ( mRNA, Adenovector and Inactivated vaccine platforms) with a goal of 2:1:1 distribution of adults from Kenya, DRC and Rwanda. The goal will be randomization of approximately 450 adults (expected 2:1 distribution of ages 18-44:45-64) per primary vaccine platform. In the control arm, a group of 300 HIV (-) adult participants (aged 18-64, inclusive) will be enrolled who have received a homologous primary series from one of the three platforms (~100/primary platform). All participants will be randomized 1:1 within their primary vaccine platform to receive a single dose of either Janssen Ad26COVS1 COVID-19 vaccine or Novavax NVX-CoV2373 COVID-19 vaccine between 5 and 7 months from completion of their primary series. 150 Active-Treatment of Control Group
Experimental Group Janssen Ad26COVS1 0.5 ml Day 0. Stage 2: In the intevention arm, study participants who are HIV positive adolescents will be randomized to receive either a single dose of Janssen Ad26COVS1 or Novavax NVX-CoV2373 vaccine at day 0. The participants will be enrolled within each primary platform ( mRNA or Adenovector/Inactivated vaccine platforms) with a goal of 2:1:1 distribution of adolescents from Kenya, DRC and Rwanda. The goal will be randomization of approximately 150 adolescents per primary vaccine platform. All participants will be randomized 1:1 within their primary vaccine platform to receive a single dose of either Janssen Ad26COVS1 COVID-19 vaccine or Novavax NVX-CoV2373 COVID-19 vaccine between 5 and 7 months from completion of their primary series. 150
Experimental Group Novavax NVX CoV2373 0.5 ml Day 0. Stage 2: In the intevention arm, study participants who are HIV positive adolescents will be randomized to receive either a single dose of Janssen Ad26COVS1 or Novavax NVX-CoV2373 vaccine at day 0. The participants will be enrolled within each primary platform ( mRNA or Adenovector/Inactivated vaccine platforms) with a goal of 2:1:1 distribution of adolescents from Kenya, DRC and Rwanda. The goal will be randomization of approximately 150 adolescents per primary vaccine platform. All participants will be randomized 1:1 within their primary vaccine platform to receive a single dose of either Janssen Ad26COVS1 COVID-19 vaccine or Novavax NVX-CoV2373 COVID-19 vaccine between 5 and 7 months from completion of their primary series. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible for the study, each HIV (+) participants must satisfy all of the following criteria: 1. Adolescent male or female aged ≥ 12 to 17 years at screening and adult male or female aged ≥ 18 to 64 years at screening (inclusive). 2. Written informed consent (and assent if adolescent), after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee. For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct. 3. Comply with study procedures, including potential home visits for COVID-19 follow-up. 4. Has completed a primary homologous vaccination series at least 3 months but no more than 6 months prior to enrollment. Vaccinations allowed include: a) mRNA (Moderna mRNA-1273 or Pfizer/BNT) – primary series is 2 doses b) Adenovector 26 (Janssen Ad26COVS1) – primary series is 1 dose; c) Inactivated whole virus (Sinopharm-BIBP) – primary series is 2 doses; 5. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 mIU/mL]) must agree to consistently use an effective method of contraception from enrolment and agree to continue adequate contraception until 12 weeks after vaccination:a. Condoms (male or female) b. Diaphragm with spermicide c. Cervical cap with spermicide d. Intrauterine device e. Oral or patch contraceptives f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®. g. Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle. NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Theseprocedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.6. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable Vital signs as determined by the Principal Investigator or designee. 7. Receiving highly active antiretroviral therapy (HAART) and using the same regimen the past 8 weeks before screening. Changes in antiretroviral dosage within 8 weeks prior to entering the study are permitted. In addition, the exchange of pharmacological formulation (e.g., the conventional formulation for combination formulations) is allowed. If regimen has changed then the participant can be reconsidered for inclusion once the 8 weeks has passed. 8. An HIV-1 viral load < 1000 copies/mL and/or CD4 Count ≥ 200 cells/mm3 within 3 months before randomization. May be taken during screening or utilize medical testing from clinic. 9. Documentation of HIV test result by HIV rapid test or assay as per the Ministry of Health guidelines in the respective countries irrespective of HIV status. Each HIV (-) participant must meet all the following criteria to be enrolled in this study: 1. Male or female aged ≥ 18 to 64 years at screening, inclusive. 2. Willing and able to give informed consent prior to study enrolment and comply with study procedures, including potential home visits for COVID-19 follow-up. 3. Has completed a primary homologous vaccination series at least 3 months but no more than 6 months prior to enrollment. Vaccinations allowed include: a. mRNA (Moderna mRNA-1273 or Pfizer/BNT) – primary series is 2 doses b. Adenovector 26 (Janssen Ad26COVS1) – primary series is 1 dose; c. Inactivated whole virus (Sinopharm-BIBP) – primary series is 2 doses;4. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 mIU/mL]) must agree to abstain from enrolment and through 6 months after the last vaccination OR agree to consistently use an effective method of contraception from enrolment and through 6 months after the last vaccination: a. Condoms (male or female) b. Diaphragm with spermicide c. Cervical cap with spermicide d. Intrauterine device e. Oral or patch contraceptives f. Hormonal Contraceptives implants or injection e.g., Norplant®, Depo-Provera®. g. Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle. NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. These procedures and laboratory test results must be confirmed by physical examination, by participant recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure. 5. Medically stable at screening, as determined by the investigator (based on review of health status, vital signs, medical history, and targeted physical examination). Acceptable vital signs by PI. 6. Documentation of negative HIV rapid test (or assay as per the Ministry of Health guidelines in the respective countries). Participants with any of the following criteria will be excluded: 1. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness of moderate or severe grade including HIV Stage III/IV or chronic illness/disease that is not stable (at the discretion of the investigator). Acute illness is a temporary exclusion for which the participant may be re-evaluated once they improve or recover. 2. Use of a heterologous COVID-19 primary series at the platform level (mRNA, Adenovector and inactivated vaccine). 3. Unstable or Severe Chronic disease inclusive of: a. Hypertension (elevated blood pressure [SBP>155mmHg or DBP>100mmHg]). Note that participants can be retested once after resting or return on another day for retesting. Participants may also have anti-hypertensive medication adjusted and may be reassessed after at least 2 weeks.b. Congestive heart failure (CHF) stage 3 or greater or diagnosed cardiovascular disease that is not controlled using medication in the past 6 months. c. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbations repeated in the past 2 years. Note: If participant has been stable the last 6 months and are not Gold stage 3 or greater, they may be included. d. Asthma stage 4 and/or unstable cases with asthma therapy adjustments in the past that 2 months. e. Type 1 or any type 2 diabetes (adult onset) with an HbA1c > 8.5 in the last 6 months. Any participant with diabetes is required to have an AIC value in last 6 months. Adolescents may not be diabetic. f. Chronic kidney disease requiring dialysis or GFR <30 (may use associated creatinine based on age and gender) g. Chronic hepatic disease with evidence of hepatic compromise. Includes known Hepatitis B or C. h. Chronic or serious neurological diseases (e.g. cerebrovascular disease (including transient ischemic attacks), autoimmune disorders, neurologic deterioration (including dementia), Guillain Barre syndrome) 4. Cognitive impairment – congenital or acquired 5. Participation in research involving an investigational product (drug/biologic/device) within 30 days prior to first study vaccination. Exception is if participant in a follow up safety phase and the investigation product has been given > 6months previously. 6. Prior receipt of an Ebola vaccine i.e., Ad26.ZEBOV/MVA-BN-Filo vaccines. 7. Received any other vaccine within 4 weeks prior to first study vaccination or planned vaccination within 2 weeks after study vaccination (exception for mass vaccination campaigns). Participants may be revaluated after the window has passed. 8. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital), excluding HIV. Note: Stable endocrine disorders that have a confirmed autoimmune etiology (e.g., thyroid, pancreatic), including stable diabetes are allowed. 9. Chronic administration (>14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 60 days prior to first study vaccination, excluding HAART. Note: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.10. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination, excluding HAART. 11. Temporary exclusion: Acute respiratory and/or non-respiratory illness consistent with potential COVID-19 infection or documented temperature of > 38°C. Note: Participant may be re-evaluated after symptoms have resolved for 3 days. 12. Positive RT-PCR SARS-CoV-2 test during screening or at time of randomization. 13. Documented SARS-CoV-2 infection in the last 3 months. May be rescreened when this period has passed. 14. Known disturbance of coagulation (iatrogenic or congenital). Note: The use of low-dose aspirin (≤ 325 mg/day) as prophylaxis is acceptable in dosages consistent with local standards of care, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease. 15. Any disease or disorder that would indicate a life expectancy less than 3 years such as active cancer. 16. Any known allergies to products contained in the investigational product or latex allergy or any history of anaphylaxis in relation to any previous vaccination. 17. Women who are breastfeeding or who are pregnant at the time of screening or plan to become pregnant within the first 12 months of the study. 18. A serious adverse event that occurs between screening and randomization. 19. History of alcohol abuse or drug addiction within 2 years prior to the first study vaccination. 20. Any condition (other than HIV) that, in the opinion of the investigator, would pose a health risk to the participant if enrolled (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 21. Study team member or first-degree relative of any study team member (inclusive of sponsor, and site personnel involved in the study). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 64 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
No 11/02/2022 AMREF Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
P O Box 30125, Wilson Airport Nairobi 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
No 25/02/2022 Rwanda National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 84 Kigali, Rwanda Kigali 84 Rwanda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 03/03/2022 National Committee of Health Ethics
Ethics Committee Address
Street address City Postal code Country
Local 5, Immeuble PNMLS, 1er Niveau, Commune of Kasa-Vubu Kinshasa Kinshasa 5 Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate reactogenicity (solicited adverse events (AEs) Ad26.COV2S1 and NVX-CoV2372 following boosting. 7 day post boosting vaccination
Primary Outcome To evaluate Serious Adverse events related to vaccination of Ad26.COV2S1 or NVX-CoV2372 during the entire study. Throughout the study period
Primary Outcome To evaluate the immunogenicity of Ad26.COV2S1 and NVX-CoV2372 vaccines at day 28 Throughout the study period
Secondary Outcome To evaluate all unsolicited AEs post-vaccination through 28 days and treatment emergent adverse events through 85 days in all participants. Throughoout the study
Secondary Outcome To evaluate safety in terms of adverse events of special interest (AESIs) following vaccination, for HIV (+) participants through end of study. Throughout Day 85 and for HIV positive participants through the EOS.
Secondary Outcome To describe severe adverse events through end of study in all participants. Throughout the study period
Secondary Outcome To compare the immunogenicity of heterologous boost in participants at Day 28 (IgG ELISA and neutralization) Baseline to day 28
Secondary Outcome To compare the durability of response through end of study (IgG ELISA and neutralization) Throughout the study period
Secondary Outcome To evaluate mucosal immunogenicity of heterologous boost in participants at Day 28 (S-IgA ELISA). Day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Victoria Biomedical Research Institute Kisumu County Hospital, P.O. Box 7180 Kisumu 40100 Kenya
University of Kinshasa Department of Tropical Medicine, Faculty of Medicine, University of Kinshasa Kinshasa Congo
Rinda Ubuzima Avenue 47 Remera Campus, PO. Box 4560 Kigali-Rwanda Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Coalition for Epidemic Preparedness Innovation Marcus Thranes gate 2, 0473 Oslo Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Victoria Biomedical Research Institute Kisumu County Hospital, P.O. Box 7180, Postal Code 40100 Kisumu 40100 Kenya VIBRI Consortium
COLLABORATORS
Name Street address City Postal code Country
Coalition for Epidemic Preparedness Innovations Marcus Thranes gate 2, 0473 Oslo Norway
Africa Clinical Research Management Ltd Kisumu Kisumu 40100 Kenya
Vincent Mutabazi CMHS/KG 11. Avenue 47 Remera Campus Kigali Rwanda
Hypolite Muhindo Faculty of Medicine, University of Kinshasa, Kinshasa XI Kinshasa Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucas Otieno Tina ltina@vibriafrica.org 00254720597654 Kisumu County Hospital
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Lucas Otieno Tina Itina@vibriafrica.org 00254720597654 Kisumu County Hospital
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Public enquiries
Role Name Email Phone Street address
Scientific Enquiries Lucas Otieno Tina Itina@vibriafrica.org 00254720597654 Kisumu County Hospital
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Scientific enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Electronic case report form(eCRF) screens will be made available to sites for data entry. Participants will not be identified by name on any data submitted to DSMB. Participants will be identified by subject numbers provided by the Clinical Data Management System upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summary will be shared when the final study clinical report is available 12 months post study completion. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Results will be shared within 12 months of study completion. To be confimed and updated once available.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be updated once 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
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/03/2022 Updated post reviewer comment. 12 months post study completion Electronic case report form(eCRF) screens will be will be made available to sites to sites for data entry. Participants will not be identified by name on any data submitted to DMC. Participants will be identified by subject numbers provided upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summarry will be shared when the final study clinical report is available 12 months post study completion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/03/2022 Updated post reviewer comment. Electronic case report form(eCRF) screens will be will be made available to sites to sites for data entry. Participants will not be identified by name on any data submitted to DMC. Participants will be identified by subject numbers provided upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summarry will be shared when the final study clinical report is available 12 months post study completion. Electronic case report form(eCRF) screens will be made available to sites for data entry. Participants will not be identified by name on any data submitted to DSMB. Participants will be identified by subject numbers provided by the Clinical Data Management System upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summarry will be shared when the final study clinical report is available 12 months post study completion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 08/03/2022 Updated post reviewer comment. URL To be confimed and updated once available.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 08/03/2022 Updated post reviewer comment. To be updated once available
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/03/2022 Updated post reviewer comment. Electronic case report form(eCRF) screens will be made available to sites for data entry. Participants will not be identified by name on any data submitted to DSMB. Participants will be identified by subject numbers provided by the Clinical Data Management System upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summarry will be shared when the final study clinical report is available 12 months post study completion. Electronic case report form(eCRF) screens will be made available to sites for data entry. Participants will not be identified by name on any data submitted to DSMB. Participants will be identified by subject numbers provided by the Clinical Data Management System upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summary will be shared when the final study clinical report is available 12 months post study completion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 10/03/2022 Updated as per reviewer comment Results will be shared within 12 months of study completion Electronic case report form(eCRF) screens will be made available to sites for data entry. Participants will not be identified by name on any data submitted to DSMB. Participants will be identified by subject numbers provided by the Clinical Data Management System upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summary will be shared when the final study clinical report is available 12 months post study completion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 10/03/2022 Updated as per reviewer comment Electronic case report form(eCRF) screens will be made available to sites for data entry. Participants will not be identified by name on any data submitted to DSMB. Participants will be identified by subject numbers provided by the Clinical Data Management System upon enrollment. Any record with participant data that leaves the site will be identified by coded number to to maintain participant confidentiality. Trial resluts summary will be shared when the final study clinical report is available 12 months post study completion. Results will be shared within 12 months of study completion.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 14/03/2022 Title updated following Protocol ammendment. A Multi-Centre, Randomized, Double Blind, Controlled Phase 2b Trial to Evaluate the Safety and Immunogenicity of Sinopharm-BIBP and Novavax NVX-CoV2373 COVID-19 vaccines Administered as Homologous and Heterologous Prime-Boost Regimens in Adolescents and Adults Aged 12 to 64 Years with and without HIV infection in 3 African Countries (Kenya, Democratic Republic of Congo, and Rwanda). A Multi-Centre, Randomized, Double Blind, Phase 2b Trial to Evaluate the Safety and Immunogenicity of Janssen Ad26COVS1 and Novavax NVX-CoV2373 COVID-19 vaccines for Homologous and Heterologous Boosting in Adolescents and Adults Aged 12 to 64 Years with and without HIV infection in 3 African Countries (Kenya, Democratic Republic of Congo, and Rwanda).
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 14/03/2022 Title updated following Protocol Ammendment. A Multi-Centre, Randomized, Double Blind, Controlled Phase 2b Trial to Evaluate the Safety and Immunogenicity of Sinopharm-BIBP and Novavax NVX-CoV2373 COVID-19 vaccines Administered as Homologous and Heterologous Prime-Boost Regimens in Adolescents and Adults Aged 12 to 64 Years with and without HIV infection in 3 African Countries (Kenya, Democratic Republic of Congo, and Rwanda). A Multi-Centre, Randomized, Double Blind, Phase 2b Trial to Evaluate the Safety and Immunogenicity of Janssen Ad26COVS1 and Novavax NVX-CoV2373 COVID-19 vaccines for Homologous and Heterologous Boosting in Adolescents and Adults Aged 12 to 64 Years with and without HIV infection in 3 African Countries (Kenya, Democratic Republic of Congo, and Rwanda).