Fifteen years ago, there was only one vaccine candidate in the clinical trial pipeline. Since then, Aeras has helped develop 9 TB vaccine candidates and conducted over 35 Phase 1-2b clinical trials. Of the 12 vaccine candidates currently in human clinical trials globally, four are supported by Aeras.
We expect results from two current clinical trials in the first half of 2018: The first is evaluating the ability of Sanofi Pasteur vaccine candidate H4:IC31 and BCG to prevent sustained infection (POI) in adolescents in a high TB-burden setting. POI is a new study design that can be used to evaluate the biologic effect of a candidate before advancing to larger, longer and more costly prevention of disease studies. Primary results from another novel late-stage clinical trial for GSK vaccine candidate M72/AS01E testing prevention of disease are expected to follow.
Continuing to explore a diverse range of vaccine candidate types will be critical to success since scientists don’t yet fully understand what type of immune response will protect people from TB. Each study conducted offers an unprecedented opportunity to apply learnings to optimize TB vaccine development.
Advancing the understanding and speed of TB vaccine science
Aeras follows globally developed criteria for selecting, assessing and advancing only the most promising vaccine candidates through the research and development pipeline, which helps ensure the best stewardship of the limited funds available for TB vaccine development. Further steps taken by Aeras to accelerate vaccine development include:
- The AerasSHARE Biorepository, launched in September 2016, which allows investigators from the broader research community to access clinical specimens collected by Aeras and its research partners to facilitate state-of-the-art TB vaccine science and promote world-wide collaboration among researchers.
- Incorporation of the latest data within TB vaccine research and development (R&D) stage gate criteria. These criteria, developed with the TuBerculosis Vaccine Initiative (TBVI), help inform and align vaccine developers on the key steps in TB vaccine development.
- Creation of improved animal models of disease to facilitate and enhance initial screening for promising TB vaccine candidates. We also worked with partners to initiate the R&D program to develop a controlled human infection model for TB, which has evolved to the Human Challenge Consortium with support from the Bill & Melinda Gates Foundation.
- Co-organizing the biennial Global Forum on TB Vaccines, which brings the global TB vaccine field together to accelerate progress.