Phase 2b controlled trial of M72/AS01E vaccine to prevent tuberculosis

Academic Article

Abstract

  • We conducted a randomized, double-blind, placebo-controlled, phase 2b trial of the M72/AS01E tuberculosis vaccine in Kenya, South Africa, and Zambia. Human immunodeficiency virus (HIV)negative adults 18 to 50 years of age with latent M. tuberculosis infection (by interferon-γ release assay) were randomly assigned (in a 1:1 ratio) to receive two doses of either M72/AS01E or placebo intramuscularly 1 month apart. Most participants had previously received the bacille Calmette-Guérin vaccine. We assessed the safety of M72/AS01E and its efficacy against progression to bacteriologically confirmed active pulmonary tuberculosis disease. Clinical suspicion of tuberculosis was confirmed with sputum by means of a polymerase-chain-reaction test, mycobacterial culture, or both.
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    Digital Object Identifier (doi)

    Author List

  • Van Der Meeren O; Hatherill M; Nduba V; Wilkinson RJ; Muyoyeta M; Van Brakel E; Ayles HM; Henostroza G; Thienemann F; Scriba TJ
  • Start Page

  • 1621
  • End Page

  • 1634
  • Volume

  • 379
  • Issue

  • 17