Reference:
South African Medical Research Council. (2021). Sisonke Protocol Version 4.4 dated 29 Apr 2021.
Summary:
The Sisonke Protocol is an open-label, single-arm phase 3B study aimed at evaluating the effectiveness of the Ad26.COV2.S COVID-19 vaccine among healthcare workers in South Africa. This study involves approximately 500,000 healthcare workers aged 18 and older, who will receive a single dose of the vaccine. The primary objective is to assess the vaccine’s effectiveness in preventing severe COVID-19, hospitalisations, and deaths, compared to the unvaccinated population. Secondary objectives include estimating the incidence of symptomatic SARS-CoV-2 infections among healthcare workers, monitoring the genetic diversity of breakthrough infections, and evaluating immunological responses. The study will also analyse the safety and uptake of the vaccine, with follow-up extending up to two years post-vaccination. Given the high incidence of COVID-19 in South Africa and the need for rapid vaccination rollout, this study aims to provide critical data to inform future vaccination strategies and address vaccine hesitancy.