Sisonke (Together): OPEN LABEL TRIAL COVID-19
- Conditions
- SARS (Severe Acute Respiratory Syndrome)
- Registration Number
- NCT04838795
- Lead Sponsor
- Wits Health Consortium (Pty) Ltd
- Brief Summary
To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa
- Detailed Description
Purpose To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population 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, 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.
Study participants Health Care workers age 18 and above working in the South African public and private health care sector (N=500 000) 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 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-cohort (approx. 850-1000 people) consisting of special sub-populations will be followed up at approx. 1, 3, 6 weeks and 6 months post vaccination. This group will also have outcomes monitored for up to a further 18 months, bringing their total follow-up duration to 2 years post-vaccination
Study products Ad26.COV2.S by Janssen administered as a single injection
Primary objectives • To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa.
Secondary objectives • 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 To monitor immunological responses (neutralising, non-neutralising antibodies and T cell responses) in HCWs with breakthrough infections
* To measure baseline SARS CoV-2 antibody testing to evaluate pre-existing immunity in up to 100 000 HCWs.
* In a subgroup of participants (approx. 850-1000 people) including representative sub-populations of interest, e.g. elderly, immune compromised:
* To compare serum neutralization and immune responses before and after vaccination at 0, 6 weeks and up to 6 months.
* To explore clotting parameters post vaccination at weeks 0, 1, 3.
* To monitor for asymptomatic infection
Exploratory objectives To set up a comprehensive safety desk and establish a link between the national pharmacovigilance system to assist with monitoring safety and any unexpected adverse effects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 477102
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa 24 Months Rates of hospitalizations and deaths among vaccinated HCWs versus general unvaccinated population
- Secondary Outcome Measures
Name Time Method The number of symptomatic SARSCoV-2 infections among vaccinated HCWs 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 HCW who are found to be RT-PCR positive at anytime up to 2 years post vaccinationThe vaccine uptake among HCWs in South Africa 12 Months Proportion of HCWs approached for study participation taking part in the study and receiving the vaccine
The measure of genetic diversity of breakthrough SARSCoV-2 infections 24 months Genetic diversity of breakthrough infection virus as determined by whole genome sequencing. This will be recovered from national laboratories.
Monitor for safety and any unexpected adverse effects of the vaccine administration -pharmacovigilance 24 Months Conduct Pharmacovigilance to monitor for safety and adverse events Numbers of safety events and/or unexpected adverse effects reported to the study team Monitor pregnancies and pregnancy outcomes reported to safety desk.
Monitoring for asymptomatic infection in a sub-set (10 000) of HCWs 24 Months Rates of asymptomatic infection at baseline and follow up using SARS CoV-2 virus and antibody testing.
Trial Locations
- Locations (31)
PHOENIX Pharma Pty Ltd
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
🇿🇦Mthatha, Eastern Cape, South Africa
Perinatal HIV Research Unit Kliptown
🇿🇦Johannesburg, Gauteng - South, South Africa
The Aurum Institute: Tembisa Clinical Research Centre
🇿🇦Johannesburg, Gauteng - South, South Africa
Josha Research
🇿🇦Bloemfontein, Free State, South Africa
CRISMO Research Centre, Dr Bhekithemba
🇿🇦Germiston, Gauteng, South Africa
Perinatal HIV Research Unit (PHRU), SOWETO
🇿🇦Johannesburg, Gauteng, South Africa
Wits RHI: Shandukani Research Centre
🇿🇦Johannesburg, Gauteng, South Africa
Themba Lethu HIV Research Unit (CHRU), Dr
🇿🇦Johannesburg, Gauteng, South Africa
Synexus SA - Stanza Clinical Research Centre
🇿🇦Pretoria, Gauteng, South Africa
Setshaba Research Centre,
🇿🇦Pretoria, Gauteng, South Africa
Synexus Watermeyer Clinical Research Centre,
🇿🇦Pretoria, Gauteng, South Africa
Ndlovu Research Centre
🇿🇦Pretoria, Gauteng, South Africa
Botha's Hill Clinical Research Site
🇿🇦Bothas Hill, KWA ZULU Natal, South Africa
Qhakaza Mbokodo Research Clinic
🇿🇦Ladysmith, 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
CAPRISA Vulindlela Clinical Research Site, Dr
🇿🇦Durban, KWA ZULU Natal, South Africa
Tongaat Clinical Research Site, Dr
🇿🇦Tongaat, Kwa Zulu Natal, South Africa
Mzansi Ethical Research Centre
🇿🇦Middleburg, Mpumalanga, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
🇿🇦Klerksdorp, North WEST Province, South Africa
FAMCRU (Family Clinical Research Unit),
🇿🇦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
Khayelitsha CRS, Dr Amy Ward / Dr Graeme Meintjes
🇿🇦Cape Town, Western CAPE, South Africa
Synexus Helderberg Clinical Research Centre, Dr Vera
🇿🇦Somerset West, 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), Dr Angelique Kany Kany
🇿🇦Worcester, Western Cape, South Africa
The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence
🇿🇦Rustenburg, South Africa
Desmond Tutu Health Foundation - Masiphumelele Research Office
🇿🇦Cape Town, South Africa