StebVax Vaccine vs. Staph Enterotoxin B
IBT is developing STEBVax, a recombinantly detoxified SEB vaccine, for the prevention of toxic shock syndrome from staphylococcus enterotoxin B (SEB) exposure due to nosocomial, environmental or potential bioterrorist events. IBT licensed STEBVax for development from the US Army Medical Research Institute of Infectious Diseases (USAMRIID).
STEBVax is currently the world’s only advanced-stage SEB vaccine candidate. STEBVax is a recombinant engineered form of SEB containing three point mutations that disrupt the interaction of the toxin with human major histocompatibility complex (MHC) class II receptors and render the protein non-toxic while retaining immunogenicity.
STEBVax has been manufactured under current Good Manufacturing Practice (cGMP). Alhydrogel-adjuvanted STEBVax is intended for intramuscular (IM) injection, achieving immune response within 14 days in a primed adult population. Multi-year stability testing indicates a favorable stability profile. In mice and nonhuman primates, STEBVax shows strong immunogenicity and 100% protection vs. SEB challenge with a good safety profile.
STEBVax’s Phase I safety trial is nearing completion, with the final results expected in Spring 2016. On completion of the trial with satisfactory human safety, STEBVax can proceed to Phase 2 studies to define adult dosing and expand the safety database. The Phase 2 data combined with results of pivotal GLP animal studies could form the basis of a data package to obtain Emergency Use Authorization (EUA) and FDA licensure under the Animal Rule.
- Ulrich et al., Development of engineered vaccines effective against structurally related bacterial superantigens, Vaccine, 1998
- Boles et al., Generation of protective immunity by inactivated recombinant staphylococcal enterotoxin B vaccine in nonhuman primates and identification of correlates of immunity, Clin Immunol, 2003
- Boles et al., Correlation of body temperature with protection against staphylococcal enterotoxin B exposure and use in determining vaccine dose-schedule, Vaccine, 2003
- Coffman et al., Production and purification of a recombinant Staphylococcal enterotoxin B vaccine candidate expressed in Escherichia coli, Protein Expr Purif, 2002
- Bavari et al., Superantigen vaccines: a comparative study of genetically attenuated receptor-binding mutants of staphylococcal enterotoxin A, J Infect Dis, 1996