Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.
- Conditions
- SARS CoV 2 Infection
- Registration Number
- NCT05148845
- Lead Sponsor
- Wits Health Consortium (Pty) Ltd
- 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
- Detailed Description
Purpose 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 the investigators will continue to evaluate VE of the Sisonke Boost compared to:
i) Vaccinated populations pre boosts ii) Unvaccinated populations in South Africa.
Study design Open-label, single-arm phase 3B vaccine implementation study
Rationale South Africa is severely affected by the global COVID-19 epidemic, and following the initial prime vaccination among HCWs in the first 4 months of 2021. New data has demonstrated the safety and effectiveness of a booster dose given two months or more after the initial Ad26.COV2.S. This provides the rationale and feasibility for the evaluation of a homologous booster vaccine dose to the cohort of vaccinated Sisonke participants to inform the larger vaccine rollout.
Study participants Sisonke participants age 18 and over working in the South African public and private health care sector (approx N=500 000) who were enrolled in Sisonke and have not subsequently had a further booster vaccine dose.
Study sites Department of Health Vaccine Administration Sites across South Africa supported by the Sisonke (Together) (VAC31518COV3012) Trial Research Site Investigators and Study Staff
Study duration Participants will receive a homologous Ad26.COV2.S (Janssen) booster dose of vaccine at least 6 months post the prime vaccination. The investigators will monitor outcomes utilising the DATCOV surveillance system and NHLS/NICD SARS COV-2 testing databases for up to 2 years post initial vaccination.
Study products Ad26.COV2.S by Janssen administered as a single dose followed by a single booster injection.
Primary objectives • To assess the effectiveness of Ad26.COV2.S vaccine as a homologous boost on severe COVID, hospitalizations and deaths in Sisonke participants as compared with the unboosted Sisonke populations.
Secondary objectives To assess the effectiveness of Ad26.COV2.S vaccine as a homologous boost on severe COVID, hospitalizations and deaths in Sisonke participants as compared vaccinated and unvaccinated populations of essential workers in South Africa.
* To estimate the incidence of symptomatic SARS CoV-2 infections in Sisonke participants following a boost compared with the unboosted Sisonke populations and general vaccinated and unvaccinated population in South Africa
* To estimate booster dose uptake among Sisonke participants in South Africa
* To monitor the genetic diversity of breakthrough SARS CoV-2 infections.
* To monitor safety in the case of homologous boosts in Sisonke participants.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500000
Not provided
- 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
- 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.
- Participants with a history of heparin-induced thrombocytopenia or TTS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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) 24 Months Rates of hospitalizations and deaths among boosted Sisonke participants versus unboosted Sisonke participants and unvaccinated populations in South Africa
- Secondary Outcome Measures
Name Time Method To estimate the incidence of symptomatic SARS CoV-2 infections among boosted Sisonke ppts. 24 months Incidence rate of SARS CoV-2 infection as indicated by self-report and validation in national laboratory records.
Rates of severe disease in Sisonke participants who are found to be RT-PCR positive at any time up to 2 years post prime vaccinationTo estimate booster vaccine uptake among Sisonke participants in South Africa 24 Months Proportion of Sisonke participants approached for study participation taking part in the boost study and receiving the booster vaccine
To monitor safety in homologous boosts 24 Months All SAEs and events of special interest will be collected and reported.
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 Rates of hospitalizations and deaths among boosted Sisonke participants versus unboosted vaccinated and unvaccinated populations in South Africa
To monitor the genetic diversity of breakthrough SARS CoV-2 infections 24 Months Genetic diversity of breakthrough infection virus as determined by whole genome sequencing. This will be recovered from national laboratories.
Trial Locations
- Locations (31)
Josha Research
🇿🇦Bloemfontein, Free State, South Africa
Emavundleni Research Centre
🇿🇦Cape Town, Western CAPE, South Africa
TASK Applied Science, Brooklyn Chest Hospital Premises
🇿🇦Cape town, Western Cape, South Africa
PHOENIX Pharma Pty Ltd
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Qhakaza Mbokodo Research Clinic
🇿🇦Ladysmith, KWA ZULU Natal, South Africa
The Aurum Institute: Tembisa Clinical Research Centre
🇿🇦Johannesburg, Gauteng - South, South Africa
Perinatal HIV Research Unit Kliptown
🇿🇦Johannesburg, Gauteng - South, 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
The Aurum Institute Clinical Research Centre, Pretoria
🇿🇦Pretoria, Gauteng, South Africa
Setshaba Research Centre,
🇿🇦Pretoria, Gauteng, South Africa
Botha's Hill Clinical Research Site
🇿🇦Bothas Hill, KWA ZULU Natal, South Africa
CAPRISA Vulindlela Clinical Research Site, Dr Disebo Makhaza
🇿🇦Durban, Kwa Zulu Natal, South Africa
CAPRISA eThekwini Clinical Research Site, Dr
🇿🇦Durban, KWA ZULU Natal, South Africa
Chatsworth Clinical Research Site
🇿🇦Durban, Kwa Zulu Natal, South Africa
TASK Applied Science, Delft Day Hospital Premises
🇿🇦Cape Town, Western Cape, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
🇿🇦Klerksdorp, North WEST Province, South Africa
Mzansi Ethical Research Centre
🇿🇦Middleburg, Mpumalanga, South Africa
Tongaat Clinical Research Site, Dr
🇿🇦Tongaat, Kwa Zulu Natal, South Africa
FAMCRU (Family Clinical Research Unit),
🇿🇦Cape Town, Western Cape, South Africa
TASK Applied Science, Dr Ivans Toms Clinic Premises
🇿🇦Cape Town, Western Cape, South Africa
TASK Clinical Research Centre
🇿🇦Cape Town, Western Cape, South Africa
TASK Central
🇿🇦Cape Town, Western Cape, South Africa
Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital
🇿🇦Cape Town, Western Cape, South Africa
South African Vaccine Initiative (SATVI)
🇿🇦Worcester, Western Cape, South Africa
TASK Eden
🇿🇦George, 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
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
🇿🇦Mthatha, Eastern Cape, South Africa
Ndlovu Research Centre
🇿🇦Pretoria, Gauteng, South Africa