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Last updated July 2012




Recombinant protein


GlaxoSmithKline Biologicals/Aeras


Phase II

GlaxoSmithKline (GSK) is working with Aeras to conduct phase II studies of GSK M72, a recombinant protein vaccine combined with a proprietary adjuvant, AS01. Early results show that the vaccine is well tolerated and induces robust polyfunctional CD4 T-cell responses against the M72 antigen that have persisted for at least three years, but no CD8 T-cell responses. No serious adverse events have occurred; the main side effects are transient local injection-site reactions. A phase II study assessing the safety and immunogenicity in HIV-positive adults with or without ART in TB endemic areas has closed to recruitment but continues to follow participants. Another ongoing phase II trial in Taiwan is assessing the impact of the vaccine in HIV-negative individuals who have received, or are currently receiving, treatment for active TB.


  • Leroux-Roels I, Forgus S, De Boever F, et al. Improved CD4(+) T cell responses to Mycobacterium tuberculosis in PPD-negative adults by M72/AS01 as compared to the M72/AS02 and Mtb72F/AS02 tuberculosis candidate vaccine formulations: A randomized trial. Vaccine. 2012 May 27. [Epub ahead of print].