Novel vaccine trial aims to answer key tuberculosis questions

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Aeras today announced the initiation of the first randomized, controlled tuberculosis (TB) vaccine trial designed to study prevention of Mycobacterium tuberculosis (Mtb) infection by vaccination. The Phase II study of the TB vaccine candidate, H4+IC31® (AERAS-404), will evaluate its safety, immunogenicity, and ability to prevent infection by Mtb, the bacterium that causes TB. The trial, which will be conducted in South Africa, will also evaluate BCG revaccination.

This novel trial design establishes a potential new paradigm in TB vaccine development. Clinical development of TB vaccines is hampered by the lack of biologic correlates of protection and lack of validated preclinical models, which could provide evidence of likely efficacy in early stages of development. The prevention of infection trial design enables a smaller, faster proof of concept to help in deciding on advancement into large-scale disease-prevention trials.While a TB vaccine would not need to prevent infection with Mtb to prevent TB disease, prevention of infection with Mtb would be an important marker of biologic impact.

“For the first time in a TB vaccine trial, we will be testing for infection by Mtb, rather than waiting to measure the occurrence of clinical disease, which is more expensive and requires much larger studies,” said Thomas G. Evans, MD, Aeras President and CEO. “This will enable us to obtain results much more quickly and with fewer subjects, and the data we generate will ensure that the entire field of TB vaccine R&D progresses in a more informed and streamlined way.”

“Right now, we do not have a reliable way to prevent people who are exposed to Mtb from becoming infected, and one out of 10 people who become infected will develop active TB disease at some point in their life,” said Associate Professor Mark Hatherill, Interim Director of SATVI. “Preventing new infections by vaccination, and interrupting the cycle of transmission, would make a tremendous impact on the TB epidemic.”

Preliminary results are expected at the end of 2015. If this initial study in adolescents shows that revaccination with BCG or vaccination with H4+ IC31® prevents infection with Mtb, then additional larger scale efficacy studies looking at the impact on TB disease in more diverse populations would be warranted.

Source:
AERAS

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