Evaluation of the Passive Protection Against Five Serotypes of Botulinum Toxin Provided by Botulinum Human Immune Globulin in an Animal Model

摘要

Botulinum Toxoid Adsorbed Pentavalent (ABCDE) vaccine is intended for human use as a prophylactic medical countermeasure for combat troops exposed to aerosolized botulinum toxins, a class of biological agents considered to be a potential warfare threat. The Food and Drug Administration (FDA) requires an assessment of efficacy before this product can be licensed. MREF Task 96-45 was conducted for the U.S. Army Medical Materiel Development Activity (USAMMDA) 0 establish a serological correlate for efficacy that could be used to establish vaccine efficacy in lieu of phase 3 clinical trials. Human immune globulin, purified from vaccinated volunteers immunized with the pentavalent botulinum toxoid, was used to passively immunize guinea pigs to establish an animal model for testing purposes. Once this model was established, animals were subsequently challenged with lethal concentrations of botulinum toxins A-E by an inhalation route to determine the minimum amount of immune globulin necessary to protect against the lethal effects of botulism.