ANTHRAX VACCINE RESEARCH PROGRAM

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Emory University, the Emory Vaccine Center, and Yerkes National Primate Research Center entered into a contractual agreement with the CDC in 2000, in response to a Congressional mandate for research to study the safety and efficacy of Anthrax Vaccine Adsorbed (AVA), the only approved anthrax vaccine currently in use in the U.S. to protect against anthrax infection. Emory University was selected as one of five sites to conduct this human clinical trial and one of two sites to carry out a similar study in non-human primates (NHP). The purpose of the human trial was two-fold: (a) to determine whether the number of AVA vaccinations could be reduced from 6 injections over an 18 month period to 3-4 injections given over a 6 month period; (b) to measure in vitro correlates of protection by measuring several parameters of immune cell function. The NHP study was designed to study: (a) immune correlates of protection following AVA vaccination in which groups of Rhesus macaques were immunized using the human AVA dose, or one of several dilutions of that dose; (b) to assess protection against anthrax infection following exposure to an aerosolized 200x lethal dose of Bacillus anthracis spores. All laboratory work on the project has been completed and the human clinical trial data was un-blinded in the third quarter of 2009.