A Medical Research and Evaluation Facility (MREF) and Studies Supporting the Medical Chemical Defense Program. Protection of Guinea Pigs by Passive Immunization With Human Botulinum Immune Globulin Obtained Post Primary Series and Post Six-Month Booster Immunizations

Abstract : Studies (MREF Tasks 95-39, 96-45, 97-51, and 97-52) have previously demonstrated a high degree of correlation between circulating neutralizing antibody titers and protection against high doses of all botulinum toxin serotypes in the guinea pig model. Neutralizing antibodies have been proposed to the FDA as a serological marker for human protection since efficacy for This vaccine cannot be directly demonstrated in traditional human clinical trials. Task 97-53 establishes the level of passive protection conferred in the guinea pig model by pretreatment with botulism immune globulin (BIG) isolated and purified from human volunteers immunized with one-of-two different Pentavalent Botulinum Toxoid Adsorbed (PBT) vaccine lots (arbitrarily designated A or B).