Covid-19
Conditions
Interventions
Sponsors
South African Medical Research Council
Fred Hutchinson Cancer Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 and older All Sisonke participants Received a priming Ad26.SARS.COV.2.S vaccination as part of the Sisonke study 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, which includes compliance with the requirements in this protocol.
Exclusion criteria
Exclusion criteria: 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 thrombosis with thrombocytopenia syndrome (TTS) The following participants will be strongly advised to discuss their participation with their practitioner/ health provider and/or the Sisonke safety desk and/or the site PI. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. Participants who are thought to have suffered a neurological adverse event considered related to the priming Janssen Covid-19 vaccine. Participants reporting a non-infective SAE within the first 28 days following the priming dose of Janssen Covid-19 vaccine in the Sisonke 3B trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
South Africa
Contacts
Public ContactGlenda Gray
National Principal Investigator
Outcome results
None listed