Anthrax vaccine-induced antibodies provide cross-species prediction of survival to aerosol challenge.

ABSTRACT: Because clinical trials to assess the efficacy of vaccines against anthrax are not ethical or feasible, licensure for new anthrax vaccines will likely involve the Food and Drug Administration's "Animal Rule," a set of regulations that allow approval of products based on efficacy data only in animals combined with immunogenicity and safety data in animals and humans. U.S. government-sponsored animal studies have shown anthrax vaccine efficacy in a variety of settings. We examined data from 21 of those studies to determine whether an immunological bridge based on lethal toxin neutralization activity assay (TNA) can predict survival against an inhalation anthrax challenge within and across species and genera. The 21 studies were classified into 11 different settings, each of which had the sam

SUBMITTER: Fay MP 

PROVIDER: S-EPMC3668972 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature