By David Njagi and Aeras
Aeras and the Infectious Disease Research Institute (IDRI) have announced the start of the first clinical trial of IDRI’s novel tuberculosis 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.
TB, which kills more people than any other infectious disease except HIV, has orphaned 10 million children, and costs the global economy an estimated one billion dollars every day.
An increasing number of diagnosed multidrug-resistant TB cases are making the disease more difficult to control and multiplying the cost and time it takes to treat patients, which can take two years or longer for multidrug-resistant TB.
The vaccine candidate targets both active tuberculosis, which makes nearly nine million people sick each year, and latent TB, which lies dormant in one-third of the world’s population and reactivates when their immune systems are compromised.
“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. “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, Ph.D., 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,” he said.
The currently available TB vaccine, Bacille Calmette-Guérin (BCG), developed 90 years ago, reduces the risk of severe forms of TB in early childhood but has been ineffective in controlling the global TB epidemic despite widespread use.