M72/AS01E is a subunit vaccine candidate comprised of an immunogenic fusion protein (M72) derived from two Mycobacterium tuberculosis (M.tb) antigens (MTB32A and MTB39A), and the GlaxoSmithKline proprietary adjuvant AS01E.
AS01E is the same adjuvant used in Shingrix GSK vaccine.
M72/AS01E is indicated to prevent Pulmonary Tuberculosis (TB)
M72/AS01E 2 doses administered intramuscularly in the deltoid region of the arm.
October 29, 2019: GSK and IAVI reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease (TB) in HIV-negative adults with latent TB infection.
These results demonstrate an overall vaccine efficacy of 50% during the three years after vaccination. The candidate vaccine has an acceptable safety and reactogenicity profile.
Clinical Trial NCT01755598: Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults
- The purpose of this Phase 2 study is to evaluate the safety, immunogenicity and protective efficacy of M72/AS01E vaccine against pulmonary TB, as compared to placebo in HIV negative adults with latent TB infection living in high TB burden countries (South Africa, Kenya, and Zambia) and aged 18 - 50 years.
- The study remains ongoing and the final analysis is planned in 2019.