TB Science Conference, 2019: Final results from M72/AS01E candidate vaccine announced

29 Oct 2019 - 17:00

Hyderabad, India: Scientists from the South African Tuberculosis Vaccine Initiative (SATVI) and the Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa) at the University of Cape Town, GlaxoSmithKline (GSK), and the International AIDS Vaccine Initiative (IAVI) have announced the final results of a large trial of the safety, immunogenicity and efficacy of the M72/AS01E candidate TB vaccine, appearing in the New England Journal of Medicine on 29 October 2019. M72/AS01E vaccination of HIV-negative adults with latent TB infection reduced the incidence of pulmonary TB by 50% over a three year period.  

To view the journal article click here. 

TB is the leading cause of infectious disease mortality. According to the World Health Organization, 10 million people fell ill with TB and 1.5 million people died from TB in 2018. Development of a new and effective vaccine to prevent progression to pulmonary TB in adults with quiescent or ‘latent’ infection with the Mycobacterium tuberculosis bacterium is key to interruption of TB transmission and control of the global TB epidemic.  

The primary objective of this study, which was conducted at 11 sites in Kenya, South Africa and Zambia, including SATVI and CIDRI-Africa at the University of Cape Town, was to evaluate the efficacy of the M72/AS01E candidate vaccine against pulmonary TB. A total of 3,575 HIV-negative, latently infected adults aged 18 to 50 years received two doses of either M72/AS01E or an inactive placebo, and were followed for three years for evidence of pulmonary TB. 13 participants in the vaccine group and 26 participants in the placebo group developed pulmonary TB, with overall vaccine efficacy of 50%. 

The results of this final analysis are consistent with results of the primary analysis after two years of follow-up, which were published in the New England Journal of Medicine in September 2018 (Van Der Meeren et al). These results confirmed the previously reported acceptable safety profile of M72/AS01E and also showed that the vaccine induced immune responses that persisted for three years.

The trial was sponsored by GSK and conducted in partnership with IAVI with funding from the Bill and Melinda Gates Foundation, the United Kingdom Department for International Development, the Government of the Netherlands Directorate-General for International Cooperation, and Australian AID.

Professor Mark Hatherill, SATVI Director said “These are game-changing results. If we can offer latently infected adults durable protection against pulmonary TB disease we may be able to interrupt the cycle of TB transmission“.

Professor Tom Scriba, SATVI Deputy Director, Immunology said “This ground-breaking study demonstrates that a vaccine can provide long-term protection against lung TB. We are also now able to decipher exactly how the immune response can protect humans against TB”.

The South African Tuberculosis Vaccine Initiative (SATVI) is a TB research group based at the Faculty of Health Sciences of the University of Cape Town. SATVI is regarded as a worldwide leader in TB vaccine research and has conducted 28 Phase I–IV trials of 9 different TB vaccine candidates since 2005.  SATVI’s research focus is understanding the risk for, and protection against, M. tuberculosis infection and disease, in order to develop more effective vaccines and preventive strategies for global impact on the TB epidemic. 

About CIDRI-Africa
The Wellcome Centre for Infectious Diseases Research in Africa fosters investigator-led approaches via the overarching scientific objective of combatting infection, especially HIV-1 and tuberculosis, through clinical and laboratory research. Three interlinked platforms support clinical studies in the community, improve the depth of laboratory investigations for infected materials, and advance cutting-edge integration of high-dimensional, big data. 

Tait DR, Hatherill M, Van Der Meeren O, Ginsberg AM, Van Brakel E, Salaun B, Scriba TJ, Akite EJ, Ayles HM, Bollaerts A, Demoitié M-A, Diacon A, Evans TG, Gillard P, Hellström E, Innes JC, Lempicki M, Malahleha M, Martinson N, Mesia Vela D, Muyoyeta M, Nduba V, Pascal TG, Tameris M, Thienemann F, Wilkinson RJ, Roman F. Final Analysis of a Trial of M72/AS01E Vaccine to Prevent Tuberculosis. New England Journal of Medicine. 2019. DOI: 10.1056/NEJMoa1909953

Additional resource:
TB Science 2019 Official Press Conference: Announcement of Results, 29 October 2019. Click here.