Phase 3 trial to assess M72/AS01E-4 Mycobacterium tuberculosis (TB) vaccine

A single injection of an experimental tuberculosis vaccine is being tested in a large-scale clinical trial to see if it can prevent the lung infection in adolescents and adults. Tuberculosis remains one of the world’s deadliest infectious diseases, killing more people each year than HIV/AIDS. The only licensed vaccine, BCG, protects infants from severe forms of TB but offers inconsistent protection against the lung form that spreads between adults and adolescents. This trial tests a new vaccine candidate, M72/AS01E-4, designed to trigger a stronger and more durable immune response against the bacterium that causes TB. If the vaccine proves effective, it could become a powerful new tool for controlling TB transmission in high-burden countries. That would reduce the strain on overstretched health systems, lower the number of people requiring lengthy antibiotic treatment, and help slow the spread of drug-resistant TB strains. The impact would be felt most directly in clinics and communities across sub-Saharan Africa, South Asia, and other regions where TB is endemic. This is a late-stage clinical trial with a clear practical goal: generating evidence that could support regulatory approval and eventual rollout of a new vaccine.