GAITHERSBURG, Md., Feb. 26, 2013 /PRNewswire/ -- Integrated BioTherapeutics (IBT) announces the initiation of a Phase 1 clinical trial testing the safety and immunogenicity of its staphylococcal enterotoxin B vaccine "STEBVAX" in healthy adults.
This trial, marking the first time a superantigen vaccine has been administered to humans, is designed to enroll 28 individuals. STEBVax is a proprietary, rationally designed and attenuated form of Staphylococcal Enterotoxin B (SEB), a member of a group of toxins called superantigens due to the ability to cause a massive inflammatory response leading to toxic shock.
"SEB is a biowarfare threat to the US and the superantigens can be critical factors affecting the outcome of Staphylococcus aureus infections," said Dr. M. Javad Aman , IBT President and Chief Scientific Officer. "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 National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have sponsored the clinical trial. The trial is being conducted at the Center for Vaccine Development at the University of Maryland in Baltimore, which is one of NIAID's Vaccine and Treatment Evaluation Units (VTEUs).
"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, a biotechnology company developing medical countermeasures for biodefense and emerging i
|SOURCE Integrated BioTherapeutics Inc|
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