Johnson & Johnson today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating its investigational single-dose COVID-19 vaccine met all primary and key secondary endpoints. The topline safety and efficacy data are based on 44,325 44 participants accruing 468 symptomatic cases of COVID-19.
The Desmond Tutu Health Foundation is a participating clinical research site in the trial, and enrolled just over 400 participants across 3 different sites at the end of 2020. DTHF COO and ENSEMBLE Co-Chair Prof Linda-Gail Bekker welcomed the news as a tremendous step forward in the fight against COVID-19. “This trial is part of a massive global effort, and our teams worked tirelessly meeting recruitment targets, all in the hope of promising news such as this. This represents the promise of a simple, effective solution that has the potential to significantly reduce the burden of this pandemic,” she said.
The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen vaccine candidate in protecting against both moderate and severe COVID-19, with co-primary endpoints of 14 days and 28 days. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall at preventing the combined endpoints of moderate and severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate and severe infection was 72% in the US, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.
The ENSEMBLE study includes clinical data regarding the safety and efficacy of a COVID-19 vaccine candidate against newly emerging strains of coronavirus, including some highly infectious variants present in the US, Latin America and South Africa. The Phase 3 ENSEMBLE trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.