論文ID: JJID.2016.360
Botulinum toxin is most poisonous substance, and it is thought to be a high risk of it being used as a biological weapon; researchers of the toxin are exposed to such a hazard. Botulinum toxoid vaccines have been produced and used in Japan. However, clinical studies using these vaccines were conducted before establishment of the Ethical Guidelines for Clinical Research in Japan, and their immunogenicity and safety using a systematic approach were not assessed. In this study, we produced new tetravalent (type A, B, E, and F) botulinum toxoid vaccine, the first derived from M toxin in the world, and conducted quality control tests with reference to the minimum requirements in Japan for adsorbed tetanus toxoid vaccine. Then, a clinical study using the new vaccine in 48 healthy adult volunteers was conducted according to the Ethical Guidelines for Clinical Research in Japan. No clinically serious adverse events were noted, and neutralizing antibody titers against each type toxin in the subjects' sera at 1 month after 4th injection were more than 0.25 IU/mL, which may ensure sufficient protection. This study indicated that the vaccine has marked immunogenicity and safety for humans.
