Highlights From Our Clinical Work in 2016
Prevention of Established Infection Trials
The first example of this new trial design and cost-efficient approach to identifying candidates with an increased probability of success is the clinical trial of the H4:IC31 vaccine candidate, which is being developed in partnership with Sanofi Pasteur, under a license from Statens Serum Institut (SSI). Conducted with the South African Tuberculosis Vaccine Initiative (SATVI) in 990 adolescents in Worcester, South Africa, the trial is the first-ever Prevention of (established) Infection (POI) trial of a new TB vaccine. This study will also evaluate if re-vaccination with the BCG vaccine could prevent established Mtb infection in high-risk adolescents within a high-force-of-infection South African setting. By testing for establishment of Mtb infection, rather than waiting for disease to occur, this novel trial design will allow us to obtain data earlier, with fewer subjects. Prevention of established infection is an important biologically relevant effect, so this type of study can generate data that may fast-track and decrease the risk in TB vaccine research and development. The study is fully enrolled and vaccinations are complete. Subjects are being followed and final analysis of results is expected by early 2018.
Efficacy Study in High-Burden Areas
Another novel trial design, which Aeras developed with our partner, GSK, is being used to evaluate efficacy of the GSK vaccine candidate M72/AS01E. This Phase 2b Prevention of Disease (POD) efficacy study enrolled 3573 adults who are Mtb-infected (QuantiFERON positive) in Kenya, Zambia and South Africa, African countries that bear some of the highest burdens of TB. This study is on track for primary analysis in 2017, with final results expected in late 2018 or early 2019.
Moving the Field Forward: Assays and Immune Responses
Aeras is collaborating with SSI, Sanofi Pasteur and the HIV Vaccine Trials Network on a Phase 1b study to evaluate the safety and immunogenicity of two vaccine candidates (H4:IC31 and H56:IC31), as well as revaccination with a licensed BCG vaccine, in 84 healthy adolescents in South Africa in partnership with the Desmond Tutu HIV Foundation . This experimental medicine study with detailed immunological assessment will evaluate assays and immune responses that could be used to identify potential correlates of protection in efficacy studies of these and other TB vaccines. Final results from this study are expected in the first half of 2017.