New investigational vaccine set to be tried in humans.

2003 JUL 2 - (NewsRx.com & NewsRx.net) -- Researchers at Saint Louis University's Center for Vaccine Development and its clinical research organization, SoLUtions, are preparing to conduct a human study of a new investigational vaccine to protect against anthrax.

VaxGen Inc., a California-based biotechnology company, is sponsoring the vaccine development and study through an accelerated program funded by the National Institute of Allergy and Infectious Diseases, a division of the U.S. National Institutes of Health.

"The goal is to develop a vaccine with better protection, an improved safety profile, and a simpler dosing schedule," said Geoffrey J. Gorse, MD, principal investigator for the study and professor of internal medicine at Saint Louis University. "The vaccine candidate we are studying contains only a single non-infectious protein, so it cannot cause anthrax."

Gorse said a total of 100 healthy volunteers, ages 18 to 40 years old, will be recruited for the study at four medical centers around the country. As many as 25 will be enrolled in St. Louis. The SoLUtions clinical research staff of Saint Louis University will provide volunteer recruitment and subject management.

Anthrax, caused by a spore-forming bacterium, is an ancient disease of animals and humans. Domestic sheep, cattle, goats, and wild herbivores have been frequent victims of the disease. Those who handle infected animals also are at risk.

Anthrax may be suitable for use in biological weapons because of the ease of spore production, the stability of the anthrax spores, and the ability to aerosolize them. In 2001, five people were killed by inhaling anthrax spores sent through the U.S. mail, spurring the U.S. government to develop an improved anthrax vaccine.

In humans, anthrax infection takes three basic forms: cutaneous, gastrointestinal, and ...