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Final analysis of a trial of M72/AS01E vaccine to prevent tuberculosis

New England Journal of Medicine Nov 07, 2019

Tait DR, Hatherill M, Meeren OVD, et al. – Researchers reported on the results of the 3-year final analysis of efficacy, safety, and immunogenicity of the M72/AS01E vaccine for tuberculosis prevention. The study sample included adults aged 18-50 years infected with Mycobacterium tuberculosis. Participants were randomized in a 1:1 ratio to receive two doses of either M72/AS01E or placebo, administered 1 month apart. Specifically, of the 3,575 participants who underwent randomization, 3,573 received at least one dose of M72/AS01E or placebo, and 3,330 received both planned doses. Among the 3,289 participants in the according-to-protocol efficacy cohort, 13 of the 1,626 participants in the M72/AS01E group—compared with 26 of the 1,663 participants in the placebo group—had cases of tuberculosis that met the first case definition. At month 36, vaccine efficacy was 49.7%. Among participants in the M72/AS01E group, the concentrations of M72-specific antibodies and the frequencies of M72-specific CD4+ T cells increased after the first dose, and were sustained throughout the follow-up period. The rate of serious adverse events, potential immune-mediated diseases, and deaths were similar between the two groups. Overall, in this study cohort infected with M. tuberculosis, M72/AS01E vaccination elicited an immune response, and provided protection against progression to pulmonary tuberculosis disease for ≥ 3 years.

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