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M72 + AS01E is an investigational subunit vaccine candidate for the prevention of pulmonary tuberculosis (TB) in adolescents and adults. The vaccine consists of a recombinant fusion protein (M72), derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the proprietary adjuvant system AS01E developed by GSK. The adjuvant enhances immune responses to the antigen. Mechanistically, the vaccine induces robust T cell-mediated immunity—particularly CD4+ T cells producing interferon-gamma—and antibody responses against Mycobacterium tuberculosis. In phase 2b clinical trials, it demonstrated approximately 50% efficacy in preventing progression from latent TB infection to active pulmonary TB over three years in HIV-negative adults. Ongoing phase 3 trials are evaluating its efficacy across broader populations, including people living with HIV and those without prior TB infection[1][3][4][5][6][7].
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