Tuberculosis (TB) continues to be a major global health threat, with the World Health Organization (WHO) reporting an estimated 10.8 million new cases and 1.25 million deaths in 2023.

While it remains one of the world’s deadliest infectious diseases and the leading cause of death amongst people living with HIV, the only available TB vaccine, Bacille Calmette-Guérin (BCG), dates back to 1921. It protects babies and young children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmission of the TB bacterium.

However, in March 2024, the Gates Medical Research Institute (Gates MRI), in partnership with the Gates Foundation, Wellcome, and GSK, launched Phase 3 clinical trials for the M72/AS01E vaccine candidate. With trial sites in South Africa, Indonesia, Kenya, Malawi, and Zambia, this new vaccine offers hope for stronger protection and better prevention of TB transmission.

The Centre for Infectious Disease Research in Zambia (CIDRZ) is among the sites participating in the Gates MRI TBV02-301 study.

At full capacity, the trial will enroll up to 20,000 participants, including people living with HIV, across 54 sites in five countries.

Participants will receive either the investigational M72/AS01E vaccine or a placebo in a double-blind trial, meaning neither the participants nor the clinical investigators will know who receives the vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.

If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century.