An open label, pragmatic, real world Phase 3b clinical trial of the investigational single-dose Janssen COVID-19 vaccine candidate among frontline healthcare workers in South Africa
As the interim analysis of the ENSEMBLE clinical trial data of Johnson & Johnson’s investigational Janssen COVID-19 vaccine candidate showed efficacy against severe COVID-19, including the B.1.351 variant, especially with regard to hospitalization and death, the South African Medical Research Council (SAMRC) is collaborating with the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) on the investigator led collaborative Sisonke (TOGETHER) study. This open label, single-arm Phase 3b vaccine implementation study of the investigational single-dose Janssen COVID-19 vaccine candidate aims to monitor the effectiveness of the investigational single-dose Janssen vaccine candidate at preventing severe COVID-19, hospitalizations and deaths among healthcare workers as compared to the general unvaccinated population in South Africa.
The study sponsor will be the South African Medical Research Council (SAMRC) and supported by National Department of Health with approval by South African Health Products Regulatory Authority (SAHPRA).
Janssen filed for Emergency Use Authorization with the U.S. FDA recently and is submitting applications for authorization to other regulators. The company has initiated a rolling submission with SAHPRA in South Africa.
The TOGETHER study will be managed by the SAMRC and conducted by clinical research sites that took part in the Phase 3 ENSEMBLE trial, in partnership with National Department of Health vaccine sites. Working with the National Vaccine Roll-Out Team, the South African programme will leverage the existing clinical trial infrastructure used for the ENSEMBLE study.