SSI and Aeras announce trial for TB vaccine candidate

Statens Serum Institute, a state-owned enterprise integrated into national Danish health services, and Aeras, a non-profit biotechnology organization, announced a new Phase I/IIa clinical trial on Friday for a candidate TB vaccine.

SSI and Aeras announced the initiation of the trial after a Phase I study raised no safety concerns and demonstrated immunogenicity from the first clinical trial of SSI H56:IC31/AERAS-456 formulated with Valneva's IC31 proprietary adjuvant. The vaccine is meant to protect people from developing active TB disease, particularly individuals latently infected with TB.

"With the results of our first study in hand, we can now test SSI H56:IC31/AERAS-456 for safety in a larger group of individuals, while looking for safety, the correct dose, and the needed immune responses that would lead us into the next phase," Thomas Evans, the president and CEO of Aeras, said. "What continues to make this project so strong is the collaboration that brings together Aeras, with deep experience in clinical trials, and SSI, which has unparalleled expertise as an innovator in the basic sciences in TB vaccinology."

The Phase I/IIa trial will test the vaccine at three dosing levels to monitor immune response and evaluate safety in HIV-negative adults with and without latent TB.

Evans said new TB vaccines are urgently needed to stop the spread of TB and halt the enormous economic burden placed on health systems around the world by multi- and extensively-drug-resistant strains.

In preclinical animal models, the vaccine candidate was shown to be protective and immunogenic before and after TB exposure.