First new TB vaccine to be tested in U.S. in more than 60 years
BETHESDA, MD – The National Institute of Allergy and Infectious Diseases (NIAID, www.niaid.nih.gov/default.htm), part of the U.S. Dept. of Health and Human Services’ National institutes of Health, reported a new vaccine, made with several proteins from the bacterium which causes tuberculosis (TB), will soon enter the first phase of human safety testing.
NIAID has supported research on the candidate vaccine from its earliest stages. The trial will be conducted in the U.S. by Seattle biotechnology company Corixa and GlaxoSmithKline Biologicals, a vaccine maker headquartered in Belgium.
"This is the first recombinant tuberculosis vaccine to reach human trials in the U.S.," said Dr. Anthony S. Fauci, NIAID director.
"Indeed, this is the first new TB vaccine to be tested in our country in more than 60 years. This candidate vaccine, [and] other novel products emerging from the TB research and development pipeline, offers hope for reducing the burden of a disease that claims approximately two million lives each year."
The vaccine combines two TB proteins known to stimulate strong immune responses in humans. The proteins were identified initially by screening blood taken from volunteers who never became ill with TB despite long-term infection with "Mycobacterium tuberculosis" bacteria. Using recombinant DNA technology, the TB proteins were fused and then combined with adjuvants, substances which further boost the immune system's response to the vaccine.
NIAID grants awarded in the late 1990s supported research which uncovered the most effective adjuvant-protein combination.
Versions of the candidate vaccine were tested in animals through an NIAID contract facility at Colorado State University. In 2000, Corixa received an NIAID "challenge" grant designed to enhance government-industry partnerships and to speed new product development. This support allowed the researchers to further advance the most promising vaccine-adjuvant combinations into animal models, including non-human primates, and to prepare and produce a vaccine candidate suitable for human trials.