Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.
Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.

NCT05148845

CompletedPhase 3

Sponsor: Wits Health Consortium (Pty) Ltd

Conditions: SARS CoV 2 Infection

Interventions: Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S, Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S

Countries: South Africa

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (31)
  • Mthatha, Eastern Cape, South Africa
  • Port Elizabeth, Eastern Cape, South Africa
  • Bloemfontein, Free State, South Africa
  • Johannesburg, Gauteng, South Africa
  • Johannesburg, Gauteng, South Africa
  • Pretoria, Gauteng, South Africa
  • Pretoria, Gauteng, South Africa
  • Pretoria, Gauteng, South Africa
  • Pretoria, Gauteng, South Africa
  • Johannesburg, Gauteng - South, South Africa
  • Johannesburg, Gauteng - South, South Africa
  • Bothas Hill, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Ladysmith, KwaZulu-Natal, South Africa
  • Tongaat, KwaZulu-Natal, South Africa
  • Middleburg, Mpumalanga, South Africa
  • Klerksdorp, North West, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • George, Western Cape, South Africa
  • Worcester, Western Cape, South Africa
  • Cape Town, South Africa
  • + 1 more on CT.gov