Integrated BioTherapeutics intiates Phase 1 trial of SEB vaccine

Integrated BioTherapeutics recently initiated a Phase 1 clinical trial of the safety and immunogenicity of its staphylococcal enterotoxin B vaccine STEBVax in heathy adults.

"SEB is a biowarfare threat to the U.S. and the superantigens can be critical factors affecting the outcome of Staphylococcus aureus infections," Dr. 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 trial is the first time that a super antigen vaccine has been administered to humans.

STEBVax is a proprietary, rationally designed and attenuated form of Staphylococcal Enterotoxin B, which is a member of a group of toxins called super antigens because of their ability to cause a massive inflammatory response leading to toxic shock.

"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."

The clinical trial is sponsored by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. The trial is being conducted at the Center for Vaccine Development at the University of Maryland in Baltimore.

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