Therapeutic Human Hyperimmune Polyclonal Antibodies Against Staphylococcal Enterotoxin B
Abstract
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 IBT's 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- May 01, 2008
- Accession Number
- ADA482581
Entities
People
- M. J. Aman