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 the approved anthrax vaccine currently in use to protect against inhalational anthrax used as a biological agent. Emory University was selected as one of the five sites for this human and NHP clinical trial. The purpose of the trial has been to reduce the number of vaccines necessary by determining when immunity successfully takes place as well as changing the route of administration of the vaccine. A second principal component of the study was an aerosol anthrax spore challenge of a vaccinated animal model (Rhesus monkeys) performed to support the data collected from a human clinical vaccine study. Two contract sites (Yerkes NPRC, Emory University, Atlanta, and Battelle Memorial Institute, Ohio) have overseen various components of the study. The animal challenge was completed with data from this study being used to support conclusions from the AVA human clinical study. During the reporting period, the PI submitted a final report analyzing the immunological results of the NHP trial to the CDC. All laboratory work on the project has been completed;when the human clinical trial data is unblinded in mid-2009, it will be analyzed by the PI to build a bridge linking the human and NHP immunological data. The contract between Emory and the CDC for the animal and laboratory portion of this project ended in December 2008, but the Human Clinical Trial portion of the project will continue at Emory until the end of 2009.
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