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Botulinum toxoid vaccine pivotal trial in guinea pigs supported by FDA advisory committee.

Executive Summary

BOTULINUM TOXOID VACCINE PIVOTAL TRIAL IN GUINEA PIGS ACCEPTABLE, members of the Vaccines and Related Biological Products Advisory Committee agreed at an Oct. 30 meeting. The proposed U.S. Army study will involve obtaining immune globulin from volunteers given the botulinum vaccine. The human antibodies will be transferred to guinea pigs through intraperitoneal injection, and the animals will then be exposed to botulinum toxins and screened for immunity.

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