Phase 2b Controlled Trial of M72/AS01E Vaccine to Prevent Tuberculosis

New England Journal of Medicine
October 25, 2018  Vol. 379 No. 17

Original Articles
Phase 2b Controlled Trial of M72/AS01E Vaccine to Prevent Tuberculosis
Olivier Van Der Meeren, M.D., Mark Hatherill, M.D., Videlis Nduba, M.B., Ch.B., M.P.H., Robert J. Wilkinson, F.Med.Sci., Monde Muyoyeta, M.B., Ch.B., Ph.D., Elana Van Brakel, M.B., Ch.B., Helen M. Ayles, M.B., B.S., Ph.D., German Henostroza, M.D., Friedrich Thienemann, M.D.,
Thomas J. Scriba, Ph.D., Andreas Diacon, M.D., Ph.D., Gretta L. Blatner, M.S., M.P.H., Marie-Ange Demoitié, M.Sc., Michele Tameris, M.B., Ch.B., Mookho Malahleha, M.D., M.P.H., James C. Innes, M.B., Ch.B., Elizabeth Hellström, M.B., Ch.B., Neil Martinson, M.B., Ch.B., M.P.H., Tina Singh, M.D., Elaine J. Akite, M.Sc., Aisha Khatoon Azam, M.B., B.S., Anne Bollaerts, M.Sc., Ann M. Ginsberg, M.D., Ph.D., Thomas G. Evans, M.D., Paul Gillard, M.D., and Dereck R. Tait, M.B., Ch.B.

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.