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The M72/AS01E candidate vaccine against tuberculosis (TB) combines two immunogenic Mycobacterium tuberculosis antigens with the AS01 adjuvant system. In phase 2 studies it induced humoral and cell-mediated immune responses in M. tuberculosis-infected adults and bacille Calmette–Guérin (BCG)-vaccinated infants. With partial industry support, investigators have now conducted a double-blind, placebo-controlled phase 2b trial to assess protection against pulmonary TB. At 11 sites in Kenya, South Africa, and Zambia they randomized HIV-negative adults (aged 18–50 years) with latent TB by interferon-γ release assay to receive 2 doses of M72/AS01E or placebo given intramuscularly 1 month apart.
Follow-up involved active and passive surveillance. Tho…