Production and immunogenic efficacy of botulinum tetravalent (A, B, E, F) toxoid

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

“…Quality control tests: The property tests of the vaccine were conducted in accordance with the Minimum Requirements in Japan for adsorbed tetanus toxoid vaccine (12), whilst potency tests (neutralizing antibody titration and toxin challenge tests) were conducted with reference to tests of previous lots of botulinum toxoid vaccine produced in Japan (8). In the property tests, contents of protein, aluminum, formaldehyde, and thimerosal were evaluated, whilst test on pH, sterility, freedom from abnormal toxicity, and detoxification were conducted.…”

“…In Japan, researchers considered active vaccination as an approach against the toxin. Consequently, investigational monovalent (type E) and tetravalent (type A, B, E, and F) botulinum toxoid vaccines were produced in 1969 (7,8). These vaccines were prepared using partially purified toxins.…”

“…In addition, the compositions of these vaccines vary between production lots. These vaccines were used on humans in Japan (7,8). However, the studies were conducted before establishment of the Ethical Guidelines for Clinical Research in Japan, and therefore, not carried out according to the corresponding guidelines or the International Conference on Harmonization (ICH) guideline for Good Clinical Practice (E6(R1)) (9,10).…”

Vaccines against botulism

“…For example, a tetravalent BoNT serotype /A, /B, /E, and /F toxoid vaccine has been engineered derived from progenitor M toxin. Vaccinated human volunteers did not show serious clinical adverse events from toxoid vaccination and antisera collected 1 month after a primary vaccination and three boosts neutralized low amounts of BoNT [48][49][50]. Another study showed nasal immunization of BoNT/A toxoid and a mutated cholera toxin yielded BoNT-specific …”

Enhancing the Protective Immune Response against Botulism

“…However, the pentavalent vaccine has lost efficacy during storage and was recently discontinued after more than 30 years of use (24). In 2002, Torii et al reported the generation of an ABEF toxoid vaccine, which is currently used to immunize at-risk workers in Japan (25,26).…”