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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 AE)
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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