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)

South African Medical Research Council0 个研究点目标入组 500,000 人开始时间: 2021年11月2日最近更新: 2024年3月4日

研究概览

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•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.

•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

发起方

South African Medical Research Council