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Completed
NCT05148845
Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.
Conditions: SARS CoV 2 Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 500000
Sponsor: Wits Health Consortium (Pty) Ltd
Location: Nelson Mandela Academic Clinical Research Unit (NeMACRU) Mthatha Eastern Cape
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
Eligibility 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 at least 6 months prior
* 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 in Appendix 5, which includes compliance with the requirements in this protocol.
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 TTS
Source: ClinicalTrials.gov (NCT05148845). StuddyBuddy aggregates publicly available trial information.