Integrated BioTherapeutics initiates trial for new bioterrorism vaccine

Integrated BioTherapeutics, a Gaithersburg, Maryland-based vaccine research company, announced the initiation on Tuesday of a Phase I clinical trial to test the safety and immunogenicity of a vaccine against staphylococcal enterotoxin B.

SEB is a member of a group of toxins called superantigens because of its ability to cause a massive inflammatory response leading to toxic shock. The trial of STEBVax, an attenuated form of SEB, is the first time a superantigen vaccine will be administered to humans.

"SEB is a biowarfare threat to the US and the superantigens can be critical factors affecting the outcome of Staphylococcus aureus infections," M. Javad Aman, IBT's president and chief scientific officer, said. "This clinical study advances our vaccine programs designed to protect military and civilian populations against the threat of SEB and our long-term goal of developing vaccines and therapeutics for Staphylococcus aureus."

The U.S. National Institute of Allergy and Infectious Diseases is sponsoring the trial, which is being conducted at the Centers for Vaccine Development at the University of Maryland in Baltimore.

"We are extremely pleased to see a decade-long research and development effort, which was heavily supported by the government, reach this critical milestone," Aman said. "Safety evaluation of STEBVax is significant as it is the first time a vaccine for such a potent toxin is being tested in humans."

IBT is dedicated to developing vaccines, immunotherapeutics and small molecules that can target emerging infectious agents, such as biological pathogens.