New Bioterrorism Vaccine Gets First Test In Humans
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 forStaphylococcus 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 being tested in humans."
For more information, visit the ClinicalTrials.gov page here.
About Staphylococcal Enterotoxin B:
The Staphylococcus aureus and Streptococcus pyogenes bacteria release superantigens during an infection. SEB is one of the most potent superantigens. When purified, SEB is a potential bioweapon and was pursued by the US and USSR prior to an international ban on offensive biological and chemical weapons. STEBVax is considered a stand-alone vaccine for biodefense applications but is also a component of IBT's multivalent vaccine for prevention and treatment of staphylococcal infections in civilian life, a pressing public health problem in light of growing antibiotic resistance. The prospective multivalent vaccine will contain additional toxoids including other attenuated superantigens and pore-forming toxins currently in pre-clinical development at IBT.