GSK and Aeras reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection in an ongoing phase IIb clinical trial testing.
These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.
Tuberculosis is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.6 million attributed deaths in 2017. It is estimated that one-quarter of the global population has latent tuberculosis infection, of whom approximately 10% will develop active pulmonary tuberculosis disease. Currently, multi-drug resistant strains of tuberculosis are emerging globally, and the only currently available vaccine against tuberculosis, BCG, does not provide proven and consistent protection in adults in tuberculosis endemic countries. Without a more effective vaccine, it will not be possible to achieve the WHO target of decreasing the number of new cases by 90% and the number of tuberculosis deaths by 95% between 2015 and 2035.
Dr. Emmanuel Hanon, Senior Vice-President and Head of R&D, Global Vaccines GSK, said:
“These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis. This scientific breakthrough – one of the very few in tuberculosis vaccine development for almost 100 years – has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.”
The primary objective of the study is to investigate if two doses of the M72/AS01E candidate vaccine can prevent adults with latent Mycobacterium tuberculosis infection from developing tuberculosis disease, compared to people who receive placebo. The study also evaluates the safety, reactogenicity and immunogenicity of the M72/AS01E candidate vaccine. The study is still ongoing and a final analysis including all efficacy, safety, reactogenicity and immunogenicity data will be performed in 2019 after all participants have completed three years of follow up.
The study is sponsored by GSK and conducted in partnership with Aeras – a non-profit organization advancing the development of new tuberculosis vaccines for the world. Funders of Aeras for this study are the Bill & Melinda Gates Foundation, the United Kingdom’s Department for International Development, the Directorate General for International Cooperation in the Netherlands, and the Australian Agency for International Development.