The Bill & Melinda Gates Medical Research Institute (Gates MRI) has initiated a large-scale Phase 3 trial to evaluate the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate in preventing pulmonary TB in adolescents and adults. The first doses were administered at the University of the Witwatersrand, Johannesburg, South Africa, marking the commencement of the trial that aims to include up to 60 sites across seven countries.

TB remains one of the world's deadliest infectious diseases, with an estimated 10.6 million people contracting the disease and 1.3 million fatalities in 2022 alone. The disease significantly impacts low- and middle-income countries, exacerbating poverty conditions. The M72/AS01E vaccine candidate, if successful, represents the first new TB vaccine in a century and a groundbreaking advance in the fight against the pulmonary form of TB, which accounts for the majority of TB transmission.

Developed through a partnership that spans decades, the vaccine candidate has shown promise in early-phase trials. GSK originally developed M72/AS01E, which Gates MRI is now advancing into Phase 3 with the support of GSK, Wellcome, and the Bill & Melinda Gates Foundation. This collaborative effort emphasizes the potential of medical innovation to address global health crises and the critical need for accessible and affordable vaccines in high-burden communities.

The trial will include a diverse participant group, encompassing up to 20,000 individuals, including those living with HIV, across South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam. The study's double-blind methodology underscores its rigor in assessing the vaccine's safety and effectiveness.

The launch of this trial is a testament to the global commitment to combating TB and the emphasis on partnership and collaboration in addressing complex health challenges. With the potential to save millions of lives and prevent tens of millions of new TB cases, the M72/AS01E vaccine candidate stands at the forefront of a transformative period in TB prevention and treatment.