London, 27 January 2020 — GlaxoSmithKline (GSK) announced today that it has licensed its M72/AS01E tuberculosis (TB) vaccine candidate to the Bill & Melinda Gates Medical Research Institute (Gates MRI), a landmark agreement that transfers responsibility for further development and potential use of the vaccine to the nonprofit organization with the goal of making it available in low-income countries with high TB burdens.
The announcement came on the heels of a phase 2b clinical trial that demonstrated the vaccine candidate's potential to reduce the incidence of active pulmonary TB by approximately 50% in HIV-negative adults with latent TB infection — a result that generated significant excitement in the global health community, given that TB remains the world's deadliest infectious disease.
A Century-Old Gap in TB Prevention
The only existing TB vaccine — the Bacille Calmette-Guérin (BCG) — has been in use for nearly a century. While BCG is effective in preventing severe TB disease in infants and young children, it provides limited protection against pulmonary TB in adolescents and adults, who accounted for 89% of people who fell ill with TB in 2018.
Developing a new vaccine against TB is a global health priority, central to accelerating progress toward ending the TB epidemic and achieving the United Nations Sustainable Development Goals. The M72/AS01E candidate represents one of the most promising advances in this effort in decades.
The Phase 2b Trial Evidence
The licensing agreement was made possible by the results of a phase 2b randomized, double-blind, placebo-controlled trial conducted in Kenya, South Africa, and Zambia with 3,573 participants. The trial, whose primary results were published in the New England Journal of Medicine in 2018 and whose final analysis was published in 2019, demonstrated that M72/AS01E provided approximately 50% to 54% efficacy in preventing active pulmonary TB disease in HIV-negative adults who already had latent tuberculosis infection.
Participants received two doses of the vaccine or a placebo, administered one month apart. The vaccine was found to have a clinically acceptable safety profile. While injection-site reactions and flu-like symptoms were more common in the vaccine group than in the placebo group, serious adverse events occurred at similar frequencies between both groups.
The Licensing Agreement
Under the terms of the agreement, the Gates MRI will lead vaccine candidate development and sponsor future clinical trials, including the eventual phase 3 efficacy trial. GSK will retain a role in future access planning and has committed to supplying the proprietary AS01E adjuvant system used in the vaccine.
Dr. Thomas Breuer, Chief Medical Officer of GSK Vaccines, said:
"At GSK, we are very proud to have developed a TB vaccine candidate which has shown promising clinical trial results in adolescents and adults where the need to combat the TB epidemic is greatest. We are delighted to announce this ambitious collaboration to enable key partners to further build on and progress our scientific innovation."
Philip Thomson, President of Global Affairs at GSK, framed the agreement as a model for sustainable global health partnerships:
"Today's new agreement signals a new and exciting phase in our efforts to improve global public health through medical innovation. For us, this type of alliance means we can take a more sustainable approach to global health, focussing our efforts and expertise on science and research, while partnering with others to ensure their development and delivery."
The Vaccine Candidate
The M72/AS01E vaccine candidate contains the M72 recombinant fusion protein, derived from two Mycobacterium tuberculosis antigens (Mtb32A and Mtb39A), combined with GSK's proprietary Adjuvant System AS01. The vaccine candidate was developed by GSK in conjunction with IAVI, a nonprofit scientific research organization.
Funding for the research that uncovered the potential of M72 was provided by multiple donors, including the United Kingdom's Department for International Development (DFID), the Directorate-General for International Cooperation (DGIS) in the Netherlands, the Australian Department for Foreign Affairs and Trade (DFAT), the European Commission, and the Bill & Melinda Gates Foundation.
Looking Ahead
If successful in future clinical trials, M72/AS01E has the potential to be the first new tuberculosis vaccine introduced in more than a century. The vaccine candidate targets pulmonary TB in adolescents and adults — the population where the disease burden is greatest and where BCG offers insufficient protection.
The licensing agreement set the stage for what would become a phase 3 clinical trial, later initiated by the Gates MRI with funding from the Bill & Melinda Gates Foundation and Wellcome. The phase 3 trial, which began in March 2024, aims to enroll 20,000 participants across multiple countries and represents the final step before potential regulatory approval and global deployment.
The burden of TB is staggering: in 2018 alone, 10 million people fell ill with the disease and 1.5 million died. Over 97% of reported cases occur in low- and middle-income countries. A vaccine that could halve the incidence of active pulmonary TB in adults with latent infection would represent a transformative tool in the global fight against one of humanity's oldest and deadliest infectious diseases.
Sources
- GSK, "GSK licenses tuberculosis vaccine candidate to the Bill & Melinda Gates Medical Research Institute for continued development," 27 January 2020
- Bill & Melinda Gates Foundation, "Bill and Melinda Gates Medical Research Institute license for continued development of M72/AS01E," January 2020
- Tait DR, Hatherill M, Van Der Meeren O, et al. "Final Analysis of a Trial of M72/AS01E Vaccine to Prevent Tuberculosis." New England Journal of Medicine, October 2019
- World Health Organization, Global Tuberculosis Report
- Gates Medical Research Institute, gatesmri.org
FIRAT Editorial Board
Institutional Research Desk · Foresight Institute of Research and Translation
The collective editorial and research translation board of FIRAT, synthesising peer-reviewed evidence, policy briefs, and division milestones across our seven foundational research pillars.
