Stop TB Partnership

New TB vaccine candidate enters clinical testing

22 August 2012 - Rockville, and Seattle - Aeras and the Infectious Disease Research Institute (IDRI) have started the first clinical trial of IDRI’s tuberculosis (TB) vaccine candidate ID93 + GLA-SE. The Phase I clinical trial will assess the safety, tolerability and immunogenicity of the vaccine candidate in 60 healthy adult volunteers. The study will be conducted by Johnson County Clin-Trials in Lenexa, Kansas, in close collaboration with Aeras and IDRI.

The vaccine candidate targets both active TB and latent TB

"An effective TB vaccine for adolescents and adults would be the single most cost-effective intervention against tuberculosis," said Tom Evans, Aeras Chief Scientific Officer. "With cases of drug-resistant TB on the rise, it is urgent to deliver an effective TB vaccine regimen to those who need it as soon as possible."

The vaccine candidate, ID93 + GLA-SE, is composed of a recombinant fusion-protein antigen designed by IDRI to recognize both active and latent TB, plus IDRI’s proprietary adjuvant, GLA-SE, which has been previously tested in humans. In pre-clinical studies, the vaccine candidate had an acceptable safety profile in animals and demonstrated substantial protection against Mycobacterium tuberculosis - the bacterium that causes TB.

"With NIH support enabling our TB program, IDRI has designed and tested the safety and efficacy of this vaccine candidate in several pre-clinical models," said Steven Reed, IDRI president, founder and Chief Scientific Officer. "The start of the first clinical trial is a significant milestone following nearly seven years of work on this vaccine candidate, which is designed to produce a robust immune response to prevent, and possibly to treat, TB."