Field Evaluation of Human Anthrax Vaccine

Patterns of antibody response in humans to the anthrax vaccine adsorbed (AVA) primary (six-dose) series☆

“…In the Brachman paper, 21 cases of cutaneous anthrax were observed (15 among placebo recipients, 3 in the observational group, and 3 who received anthrax vaccine). Of the three cases of cutaneous anthrax among partially vaccinated subjects, none had received the 6-month dose of anthrax vaccine [23]. One case occurred 5 months after third dose, but before the first of three 6-month boosters.…”

“…No cases of anthrax disease have been observed among individuals receiving the 6-month dose of AVA [23,24]. In the Brachman paper, 21 cases of cutaneous anthrax were observed (15 among placebo recipients, 3 in the observational group, and 3 who received anthrax vaccine).…”

“…The single case in the incompletely immunized individual, 13 months after the initial series, further supports the importance of the first booster inoculations in securing adequate protective levels." [23].…”

Development of an in vitro-based potency assay for anthrax vaccine

“…Because knowledge of the protection afforded by anthrax vaccines is limited [26] by reason of ethical constraints in evaluating efficacy in humans directly, surrogates are required as a means to predict human efficacy. Thus, the potency test selected should be such that it could function as a surrogate to predict the efficacy of the product in humans.…”

Safety, Reactogenicity, and Immunogenicity of a Recombinant Protective Antigen Anthrax Vaccine Given to Healthy Adults

“…4 This vaccine is highly protective against inhalational B. anthracis spore challenge in rabbits and monkeys. 5 A similar vaccine had 92.5% efficacy against clinical anthrax among workers in New England wool mills in the middle of the last century, 6 but no other human efficacy trials have ever been performed. The vaccine has been recommended pre-exposure for members of the U.S. Armed Forces, for some laboratory workers, and for others who may be occupationally exposed.…”