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Chapter 8: Availability, Safety, and Efficacy of Drugs and Other Therapies | Chemical and Biological Terrorism: Research and Development to Improve Civilian Medical Response | Committee on R&D Needs for Improving Civilian Medical Response to Chemical and Biological Terrorism Incidents | Health Science Policy Program | Institute of Medicine and | Board on Environmental Studies and Toxicology | Commission on Life Sciences | National Research Council

TABLE 8-6
Potential Countermeasures for Botulism

Antidote Efficacy Availability Potential
Civilian Utility
Stockpile
Active immunization:
vaccine (toxoid of serotypes A—E)
Formalin-fixed crude culture supernatant from strains producing appropriate serotypes vaccination 0, 2, and 12 weeks with annual booster.
~ 80% of recipients exhibit protective titers (CDC standard > 0.25 IU/ml) at 14 weeks; at 1 year booster almost none with measurable titer. Booster results in 90% of individuals with good response. Fully protects animals from all routes of challenge. Investigational (IND) Preexposure
Task force
Health dept.
Passive immunization:
Horse antibotulism serum (globulin) A despeciated globulin treated with Pepsin to produce F(ab1)2
Basic immunoglobulin molecule altered by removing complement- fixing (Fc) region to concentrate antigen binding sites.
Decreases risk of serum sickness of older equine version: Studied in monkeys with serotype A prevents disease development if pretreated. When given after exposure protective if given before the onset of clinical signs. If given after the onset of symptoms, no protection. Research Yes
Postevent
Prehospital and postexposure high-risk
Health dept.
Recombinant vaccines Will enhance safety Investigational   N/A
Monoclonal antibodies Will enhance safety Investigational   N/A
Aminopyridines (3,4-diaminopyridine)a Limited success with prevention and reversal of muscle paralysis for human serotype A. in animal studies. No effect for other serotypes. High toxicity potential. Not under further study.   N/A
Chimer of receptor binding protein for botulinum molecule (either monoclonal antibody or drug to neutralize intracellularly) Preclinical studies only Research   N/A
Botulism immune globulin harvested from human donors experimentally exposed to toxoidb Longer biological half life with prolonged effective level Investigational Preexposure, postevent Prehospital and postexposure high-risk Health dept.

aSiegel et al., 1986; bFrankovich and Arnon, 1991.


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