SLU study to use various assays for new TB vaccine development

Published on November 29, 2012 at 9:24 AM · No Comments

A pilot study at Saint Louis University Center for Vaccine Development could shape the future of tuberculosis vaccine research by developing tests to identify the most promising vaccine candidates to address this global health crisis.

"Our goal is to save lives faster," said Daniel Hoft, M.D., Ph.D., director of the division of infectious diseases, allergy and immunology at SLU. "We hope to develop a process that will allow us to screen new TB vaccines for inducing immunity in people, which will get us on the right research track faster and save valuable research dollars."

It's critical to find a vaccine to protect people from tuberculosis, which the World Health Organization has declared a global health emergency. The Mycobacterium tuberculosis pathogen that causes TB is one of the world's deadliest infectious agents, costing an estimated two million lives a year. Further, treating the illness is becoming increasingly difficult because new strains of TB do not respond to antibiotics.

The current TB vaccine that is given to infants in countries other than the U.S. was developed more than 60 years ago and is known as BCG (Bacillus Calmette-Guérin). Made from a weakened strain of live bacterium from cows, the vaccine protects babies from the worst forms of TB. However, it does not protect adolescents and adults from pulmonary TB, which accounts for most cases of the disease, or protect people from the progression of tuberculosis bacteria that lies dormant in the body before it turns into active disease in 10 percent of carriers.

According to Aeras, a multi-national non-profit organization dedicated to developing effective TB vaccines and treatments, conducting the scientific testing on the safety and effectiveness of a vaccine takes between 13 and 16 years before the vaccine can be licensed and available in the marketplace.

Information from Aeras notes the direct cost to develop a single TB vaccine for one specific target group could be as high as $315 million. The lion's share of the research cost - up to $265 million -- is for a phase III efficacy trial that could include many thousands of people and lasts about four years. A phase III study is the final step in the research process before a vaccine can be licensed for use.

Hoft said TB vaccine research is complicated partly because so many people carry the TB bacteria and never develop disease. In addition, there is not an ideal animal model for testing TB vaccines, a necessary step before they are given to human volunteers.

Hoft is not testing a specific vaccine; rather he is testing the vaccine testing process through a challenge screening protocol. A challenge protocol "challenges" the body's immune system to see if it can mount a response that fights against a foreign invader.

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