Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.
Sisonke Boost
Open-label, Single-arm Phase 3B Implementation Study to Evaluate the Effectiveness of the Homologous Boostof Ad26.COV2.S COVID-19 Vaccine Following the Prime Dose Among Sisonke Participants in South Africa(VAC31518COV30XX)
1 other identifier
interventional
500,000
1 country
31
Brief Summary
To evaluate the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine plus a homologous boostwith Ad26.COV2.S COVID-19 vaccine among Sisonke participants as compared to unboosted Sisonkeparticipants; vaccinated; and unvaccinated populations in South Africa
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2021
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2021
CompletedStudy Start
First participant enrolled
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 1, 2022
December 1, 2021
3 months
November 9, 2021
July 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the effectiveness of Ad26.COV2.S (Janssen) boost vaccine on severe COVID, hospitalizations and deaths in Sisonke participants as compared to unboosted Sisonke participants (single Ad26 vaccine only)
Rates of hospitalizations and deaths among boosted Sisonke participants versus unboosted Sisonke participants and unvaccinated populations in South Africa
24 Months
Secondary Outcomes (5)
To assess the effectiveness of Ad26.COV2.S (Janssen) boost vaccine on severe COVID, hospitalizations and deaths in Sisonke participants as compared to the vaccinated and unvaccinated populations (no vaccination) in South Africa.
24 Months
To estimate the incidence of symptomatic SARS CoV-2 infections among boosted Sisonke ppts.
24 months
To monitor the genetic diversity of breakthrough SARS CoV-2 infections
24 Months
To estimate booster vaccine uptake among Sisonke participants in South Africa
24 Months
To monitor safety in homologous boosts
24 Months
Interventions
To evaluate the effectiveness and safety of the single dose Ad26.COV2.S (Jansen) COVID-19 vaccine plus a homologous boost with Ad26.COV2.S (Janssen) COVID-19 vaccine among Sisonke participants as compared to unboosted Sisonke participants In addition we will continue to evaluate VE of the Sisonke Boost compared to: i) Vaccinated populations pre boosts ii) Unvaccinated populations in South Africa.
Eligibility Criteria
You may qualify if:
- Age 18 and older
- All Sisonke participants
- Received a priming Ad26.SARS.COV.2.S vaccination as part of the Sisonke study at least 6 months prior
- Participants who are pregnant or report breastfeeding at the time of enrolment may be included.
- Willingness and ability to comply with 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.
You may not qualify if:
- Participants who have received boosting vaccination through other means.
- 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
- Participants with a history of heparin-induced thrombocytopenia or TTS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wits Health Consortium (Pty) Ltdlead
- National Department of Health of South Africacollaborator
- National Institute of Communicable Diseases - NICDcollaborator
- KwaZulu-Natal Research Innovation and Sequencing Platform - KRISPcollaborator
- Fred Hutchinson Cancer Centercollaborator
- Hutchinson Center Research Institute of South Africa (HCRISA)collaborator
- Janssen Vaccines & Prevention B.V.collaborator
- Bio Analytical Research Corporationcollaborator
- Dis-Chem Pharmacycollaborator
- BioVaccollaborator
- Biocaircollaborator
- Right to Carecollaborator
- Clinical Laboratory Servicescollaborator
- Institute of Infectious Disease and Molecular Medicinecollaborator
Study Sites (31)
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, Eastern Cape, 5100, South Africa
PHOENIX Pharma Pty Ltd
Port Elizabeth, Eastern Cape, 6001, South Africa
Josha Research
Bloemfontein, Free State, 9300, South Africa
Perinatal HIV Research Unit (PHRU), SOWETO
Johannesburg, Gauteng, 1862, South Africa
Clinical HIV Research Unit (CHRU),
Johannesburg, Gauteng, 2000, South Africa
MeCRU Clinical Research Unit
Pretoria, Gauteng, 0000, South Africa
Setshaba Research Centre,
Pretoria, Gauteng, 0152, South Africa
The Aurum Institute Clinical Research Centre, Pretoria
Pretoria, Gauteng, 2059, South Africa
Ndlovu Research Centre
Pretoria, Gauteng, South Africa
The Aurum Institute: Tembisa Clinical Research Centre
Johannesburg, Gauteng - South, 1632, South Africa
Perinatal HIV Research Unit Kliptown
Johannesburg, Gauteng - South, 1809, South Africa
Botha's Hill Clinical Research Site
Bothas Hill, KwaZulu-Natal, 3660, South Africa
CAPRISA eThekwini Clinical Research Site, Dr
Durban, KwaZulu-Natal, 4001, South Africa
Chatsworth Clinical Research Site
Durban, KwaZulu-Natal, 4030, South Africa
CAPRISA Vulindlela Clinical Research Site, Dr Disebo Makhaza
Durban, KwaZulu-Natal, South Africa
Qhakaza Mbokodo Research Clinic
Ladysmith, KwaZulu-Natal, 3370, South Africa
Tongaat Clinical Research Site, Dr
Tongaat, KwaZulu-Natal, 4400, South Africa
Mzansi Ethical Research Centre
Middleburg, Mpumalanga, 1050, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
Klerksdorp, North West, 2571, South Africa
TASK Applied Science, Delft Day Hospital Premises
Cape Town, Western Cape, 7100, South Africa
TASK Applied Science, Dr Ivans Toms Clinic Premises
Cape Town, Western Cape, 7100, South Africa
FAMCRU (Family Clinical Research Unit),
Cape Town, Western Cape, 7505, South Africa
TASK Applied Science, Brooklyn Chest Hospital Premises
Cape Town, Western Cape, 7530, South Africa
TASK Central
Cape Town, Western Cape, 7530, South Africa
TASK Clinical Research Centre
Cape Town, Western Cape, 7530, South Africa
Emavundleni Research Centre
Cape Town, Western Cape, 7781, South Africa
Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital
Cape Town, Western Cape, 7925, South Africa
TASK Eden
George, Western Cape, 6529, South Africa
South African Vaccine Initiative (SATVI)
Worcester, Western Cape, 6850, South Africa
Desmond Tutu Health Foundation - Masiphumelele Research Office
Cape Town, 7975, South Africa
The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence
Rustenburg, 0299, South Africa
Related Publications (1)
Takalani A, Robinson M, Jonas P, Bodenstein A, Sambo V, Jacobson B, Louw V, Opie J, Peter J, Rowji P, Seocharan I, Reddy T, Yende-Zuma N, Khutho K, Sanne I, Bekker LG, Gray G, Garrett N, Goga A; Sisonke Study Team. Safety of a second homologous Ad26.COV2.S vaccine among healthcare workers in the phase 3b implementation Sisonke study in South Africa. Vaccine. 2024 Feb 27;42(6):1195-1199. doi: 10.1016/j.vaccine.2024.01.066. Epub 2024 Jan 25.
PMID: 38278629DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glenda Gray, MBChB
Non-Executive Director
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2021
First Posted
December 8, 2021
Study Start
November 10, 2021
Primary Completion
January 31, 2022
Study Completion
June 1, 2023
Last Updated
August 1, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Within 12 months of completion of study
- Access Criteria
- on request
All study team scientists will disseminate the trial results as broadly as possible. Data will be shared with JNJ prior to release to the public. The study data will be published consistent with normal scientific practices. The results from this research may also be disseminated through presentations at scientific institutions/ meetings, and/or publication in scientific journals. All publications will be uploaded to a publication repository. After sharing the results with study participants, they will be presented to communities from which participants are recruited, following Good Participatory Practice guidelines. The results will also be shared with global and local policy makers. Summary results of the trial will be made publicly available through the clinical trial registry. Any datasets used for analysis in publications can be requested by investigators via an online request to the organisation. Measures will be taken to protect identifiable information in the datasets