Vaccine Info

M72/AS01E (M72) Tuberculosis Vaccine

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Last reviewed
June 29, 2023
Fact checked by
Robert Carlson, MD

M72/AS01E (M72) Tuberculosis Vaccine Candidate 2023

M72/AS01E (M72) is a subunit vaccine candidate which contains the M72 recombinant fusion protein derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with the GlaxoSmithKline plc (GSK) proprietary Adjuvant System AS01. AS01E is the same adjuvant used in GSK's Shingrix® shingles vaccine. M72/AS01E is indicated to prevent Pulmonary Tuberculosis (TB) in adolescents and adults.

The M72/AS01E vaccine candidate was developed by GSK in partnership with AERAS since the early 2000s. It was developed by GSK up to the proof-of-concept phase Phase IIb study. In the Phase IIb trial, M72 showed approximately 50% efficacy in reducing pulmonary TB in adults with latent TB infection. In July 2019, the World Health Organization (WHO) convened in Geneva, Switzerland, a meeting to generate consensus on the clinical development pathway for the M72/AS01E vaccine candidate. In 2020, the Bill & Melinda Gates Foundation out-licensed M72/AS01E to the Gates Medical Research Institute (MRI).

On June 28, 2023, Wellcome and the Gates Foundation announced funding to advance M72/AS01E (M72) through a Phase III clinical trial. To support the M72 Phase III clinical trial, which will cost an estimated US$550 million, Wellcome is providing up to US$150 million, and the Gates Foundation will fund the remainder, about US$400 million.

M72/AS01E (M72) Tuberculosis Vaccine Indication

TB is estimated that 25% of the global population has latent TB infection, of whom approximately 10% will develop active pulmonary TB disease.

M72/AS01E (M72) Tuberculosis Vaccine Dosage

M72/AS01E two doses are administered intramuscularly in the deltoid region of the arm.

M72/AS01E (M72) Tuberculosis Vaccine News

June 28, 2023 - Bill Gates, the co-chair of the Bill & Melinda Gates Foundation, commented in a press release, "Greater investment in safe and effective TB vaccines alongside a suite of new diagnostics and treatments could transform TB care for millions of people, saving lives and lowering the burden of this devastating and costly disease."

May 10, 2022 - AFP reported that the M72 TB vaccine could save tens of thousands of South African lives yearly but only be available in 2030.

December 20, 2021 - A Multi-country, Epidemiologic Study to Assess the Interferon Gamma Release Assay (IGRA) Positivity and Build Capacity to Conduct a Tuberculosis (TB) Vaccine Efficacy Study in Populations With a High TB Disease Burden.

June 30, 2020 - The WHO published - Vaccines and Immunization: Investigational vaccine candidate M72/AS01E: FAQs.

January 27, 2020 - London-based GSK announced that it had licensed its M72/AS01E tuberculosis disease vaccine candidate to the Bill & Melinda Gates Medical Research Institute (MRI).

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. In addition, the candidate vaccine has an acceptable safety and reactogenicity profile.

September 25, 2018 - Results from Phase 2b Controlled Trial of M72/AS01 E Vaccine to Prevent Tuberculosis. Conclusions: M72/AS01E provided 54% protection for M. tuberculosis-infected adults against active pulmonary tuberculosis disease without evident safety concerns. 

Clinical Trial

Clinical Trial NCT01755598:  Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals' Candidate TB Vaccine in Adults. The results showed that administering two doses of M72/AS01E successfully reduced the development of active TB disease with 50% efficacy (90% CI, 12 to 71) in HIV-negative adults with latent Mycobacterium tuberculosis infection. A total of 39 participants contributed to the primary vaccine efficacy analysis during three years of follow-up: 13 participants vaccinated with M72/AS01E developed pulmonary TB compared to 26 participants in the placebo group.

Clinical Trials

No clinical trials found