The Kenya Medical Research Institute (KEMRI) has launched a pivotal Phase 3 clinical trial for the M72/AS01E tuberculosis (TB) vaccine candidate, marking a significant advancement in the global fight against one of the deadliest infectious diseases. The trial, which commenced in July 2024, places Kenya at the forefront of efforts to develop a more effective TB vaccine, particularly for adults and adolescents—the populations most affected by the disease.
According to the World Health Organization (WHO), TB remains a leading health threat, with 10.6 million new cases and 1.3 million deaths reported in 2022. In Kenya, 128,000 new TB cases are diagnosed annually. The Bacille Calmette-Guérin (BCG) vaccine, in use for nearly a century, offers limited protection, especially for adults. The M72/AS01E vaccine, developed by GSK, has shown great promise in earlier trials and could revolutionize TB prevention.
KEMRI’s trial is part of a multinational effort, involving over 20,000 participants across countries such as South Africa, Zambia, and Indonesia. Kenya, the second country to join after South Africa, is conducting trials at nine locations. Led by Dr Videlis Nduba and Dr Carolyne Ndila, the trial aims to evaluate the vaccine’s safety and effectiveness through a randomized, double-blind study.
A successful outcome could lead to the first new TB vaccine in over 100 years, potentially saving millions of lives and reducing transmission globally. Sponsored by the Bill & Melinda Gates Medical Research Institute, the trial could be a major milestone in eradicating TB worldwide.
Article by Nyokabi Wanjiku
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