Clinical Study of New Tetravalent (Type A, B, E, and F) Botulinum Toxoid Vaccine Derived from M Toxin in Japan

Japanese journal of infectious diseases

Yasushi Torii¹  Kazunori Morokuma²  Yoshikane Horikawa²  Nakaba Sugimoto³  Shunji Kozaki³  Motohide Takahashi⁴  Tomoko Kohda⁴  Akihiro Ginnaga⁴  Akihiko Yamamoto⁴ 

[1] Department of Animal Science, Tokyo University of Agriculture;Department of Veterinary Sciences, Graduate School of Life and Environmental Sciences, Osaka Prefecture University;Graduate School of Medicine, Osaka University;The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)

关键词: botulinum toxoid vaccine;    quality control tests;    clinical study;    neutralizing antibody;   

DOI  :  10.7883/yoken.JJID.2016.360

学科分类：传染病学

来源: National Institute of Infectious Diseases

【 摘 要 】

Botulinum toxin is the most poisonous substance known, and is believed to be a highly lethal as a biological weapon; researchers of the toxin are exposed to this hazard. Botulinum toxoid vaccines have been produced and used in Japan. However, since clinical studies involving these vaccines were conducted before establishment of the Ethical Guidelines for Clinical Research in Japan, their immunogenicity and safety were not systematically assessed. In this study, we produced a new tetravalent (type A, B, E, and F) botulinum toxoid vaccine, the first ever to be derived from M toxin, and conducted quality control tests with reference to the Minimum Requirements in Japan for adsorbed tetanus toxoid vaccine. Subsequently, a clinical study using the new vaccine in 48 healthy adult volunteers was conducted according to the guidelines in Japan. No clinically serious adverse event was noted. Neutralizing antibody titers for each type of toxin in the participants’ sera, 1 month after the 4th injection were more than 0.25 IU/mL, indicating sufficient protection. This study demonstrated that the vaccine has marked immunogenicity and is safe for use in humans.

【 授权许可】

Unknown