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 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, M.D., 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 bacteria, 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 inhalational. "The most common form is cutaneous anthrax, accounting for greater than 95 percent of the cases," Gorse said. "In these cases infection occurs through a skin cut or abrasion. If untreated, 10 to 20 percent of cases could be fatal."
Gastrointestinal anthrax, very uncommon in humans, is contracted by the ingestion of meat contaminated with Bacillus anthracis. The course of the disease includes acute gastroenteritis, abdominal pain and bloody diarrhea. Left untreated, gastrointestinal anthrax may have a fatality rate of up to 60 percent.
"Inhalational anthrax is the most fatal form, though very rarely encountered, with fewer than 100 naturally occurring cases reported worldwide each year," said Robert Belshe, M.D., director of the Center for Vaccine Development at Saint Louis University. "Left untreated, the fatality rate is almost 100 percent for inhalational anthrax."
Although the current anthrax vaccine has been shown to be effective in preventing cutaneous anthrax, its dosing schedule - six doses over 18 months - and the need for annual boosters are cumbersome. The vaccine candidate being studied at Saint Louis University is designed to require only three injections.
Volunteers in the trial will be divided into four groups of 25. Within each subgroup, 20 of the 25 volunteers will receive VaxGen's investigational anthrax vaccine in one of four different dosing levels; the remaining five will receive the currently licensed anthrax vaccine, Anthrax Vaccine Adsorbed (BioThraxTM). All volunteers will be compensated for participating in the study.
For more information on participating in this trial, call Susan E. Hillyard, SoLUtions' Clinical Research Coordinator, at Saint Louis University at (314) 977-7530 or the SLUCare Call Center at (314) 268-5880.
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