With 6,940 newborns enrolled across five African countries, this was the largest randomized trial of a recombinant BCG vaccine in newborns and the first to report Phase 3 efficacy data across multiple African countries.
Beyond the individual endpoints, this study reflects an extraordinary international effort involving participating families, clinical teams, researchers, funders, and partners. It generated important safety, feasibility, and methodological insights that can help inform the design of future tuberculosis vaccine trials in infants.
We thank everyone across the priMe consortium who made this work possible. We also gratefully acknowledge the Serum Institute of India Pvt. Ltd. as the trial sponsor, as well as the support of the European & Developing Countries Clinical Trials Partnership (EDCTP) and the European Investment Bank (EIB).
Read the publication: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(26)00374-9/abstract
