Therapeutic Human Hyperimmune Polyclonal Antibodies Against Staphylococcal Enterotoxin B
Final rept. 19 Oct 2007-18 Apr 2008
INTEGRATED BIOTHERAPEUTICS INC GERMANTOWN MD
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This SBIR project aims to develop hyperimmune human polyclonal antibody that neutralizes the toxic activity of staphylococcal enterotoxin B SEB as treatment for toxic shock induced by SEB disseminated as aerosol in a biowarfare scenario. The primary goal of Phase I was to demonstrate the feasibility of therapeutic intervention with immunoglobulin enriched with antibodies against SEB. Feasibility of the approach was demonstrated in cellular assays and a mouse model of SEB induced toxic shock. IVIG and specific human anti-SEB antibodies purified from IVIG was used as a surrogate for hyperimmune globulin. It was demonstrated that human polyclonal antibodies can potently inhibit the toxicity of SEB. Antibodies were also able to protect mice from lethal challenge with SEB. Several cell based assays and respective SOPs were developed for testing the neutralizing activity of human polyclonal antibodies toward SEB. These assays will be used in Phase II to test the activity of sera from individuals vaccinated with IBTs recombinant SEB vaccine STEBVax. Immunoglobulin will be purified from plasmapheresed vaccinated individuals to conduct preclinical efficacy studies in animal models of SEB toxic shock. It is anticipated that the Phase II project will result in a strong candidate for clinical development.