articleNew England Journal of MedicineOct 29, 2019BRONZE OA

Final Analysis of a Trial of M72/AS01 E Vaccine to Prevent Tuberculosis

TuBerculosis Vaccine Initiative · South African Tuberculosis Vaccine Initiative · +21 more institutions

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Abstract

Background Results of an earlier analysis of a trial of the M72/AS01E candidate vaccine against Mycobacterium tuberculosis showed that in infected adults, the vaccine provided 54.0% protection against active pulmonary tuberculosis disease, without evident safety concerns. We now report the results of the 3-year final analysis of efficacy, safety, and immunogenicity. Methods From August 2014 through November 2015, we enrolled adults 18 to 50 years of age with M. tuberculosis infection (defined by positive results on interferon- release assay) without evidence of active tuberculosis disease at centers in Kenya, South Africa, and Zambia. Participants were randomly assigned in a 1:1 ratio to receive two doses of…

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