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Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.
Sponsor: Wits Health Consortium (Pty) Ltd
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
Official title: Open-label, Single-arm Phase 3B Implementation Study to Evaluate the Effectiveness of the Homologous Boost of Ad26.COV2.S COVID-19 Vaccine Following the Prime Dose Among Sisonke Participants in South Africa(VAC31518COV30XX)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500000
Start Date
2021-11-10
Completion Date
2023-06-30
Last Updated
2026-09-01
Healthy Volunteers
Yes
Conditions
Interventions
Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S
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.
Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S
Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S
Locations (31)
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, Eastern Cape, South Africa
PHOENIX Pharma Pty Ltd
Port Elizabeth, Eastern Cape, South Africa
Josha Research
Bloemfontein, Free State, South Africa
Perinatal HIV Research Unit (PHRU), SOWETO
Johannesburg, Gauteng, South Africa
Clinical HIV Research Unit (CHRU),
Johannesburg, Gauteng, South Africa
MeCRU Clinical Research Unit
Pretoria, Gauteng, South Africa
Setshaba Research Centre,
Pretoria, Gauteng, South Africa
The Aurum Institute Clinical Research Centre, Pretoria
Pretoria, Gauteng, South Africa
Ndlovu Research Centre
Pretoria, Gauteng, South Africa
The Aurum Institute: Tembisa Clinical Research Centre
Johannesburg, Gauteng - South, South Africa
Perinatal HIV Research Unit Kliptown
Johannesburg, Gauteng - South, South Africa
Botha's Hill Clinical Research Site
Bothas Hill, KwaZulu-Natal, South Africa
CAPRISA eThekwini Clinical Research Site, Dr
Durban, KwaZulu-Natal, South Africa
Chatsworth Clinical Research Site
Durban, KwaZulu-Natal, South Africa
CAPRISA Vulindlela Clinical Research Site, Dr Disebo Makhaza
Durban, KwaZulu-Natal, South Africa
Qhakaza Mbokodo Research Clinic
Ladysmith, KwaZulu-Natal, South Africa
Tongaat Clinical Research Site, Dr
Tongaat, KwaZulu-Natal, South Africa
Mzansi Ethical Research Centre
Middleburg, Mpumalanga, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
Klerksdorp, North West, South Africa
TASK Applied Science, Delft Day Hospital Premises
Cape Town, Western Cape, South Africa
TASK Applied Science, Dr Ivans Toms Clinic Premises
Cape Town, Western Cape, South Africa
FAMCRU (Family Clinical Research Unit),
Cape Town, Western Cape, South Africa
TASK Applied Science, Brooklyn Chest Hospital Premises
Cape Town, Western Cape, South Africa
TASK Central
Cape Town, Western Cape, South Africa
TASK Clinical Research Centre
Cape Town, Western Cape, South Africa
Emavundleni Research Centre
Cape Town, Western Cape, South Africa
Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital
Cape Town, Western Cape, South Africa
TASK Eden
George, Western Cape, South Africa
South African Vaccine Initiative (SATVI)
Worcester, Western Cape, South Africa
Desmond Tutu Health Foundation - Masiphumelele Research Office
Cape Town, South Africa
The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence
Rustenburg, South Africa