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. Anthrax Vaccine, Adsorbed (AVA) is currently the only vaccine licensed in the United States for protection against human anthrax. The licensed regimen for AVA is subcutaneous (SQ) administration of a series of 6 primary doses followed by annual booster doses. In response to concerns about the use of the vaccine in the US military, in Fiscal Year 2001 the US Congress appropriated funds to CDC to study the efficacy and safety of the vaccine. A principal component of this Anthrax Vaccine Research Program (AVRP) is a 43-month human study of immunogenicity and reactogenicity elicited by AVA given by different routes of administration (SQ versus IM) and dosing regimens (as many as 8 doses versus as few as 4 doses). Emory University was selected as one of the five sites for this human clinical trial. A second principal component of the study, undertaken at the recommendation of the Food and Drug Administration (FDA), 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. This immune response-protection relationship can be bridged to support the human clinical study by predicting the likelihood that human clinical study volunteers would be protected based on their immune response to the vaccine. Two contract sites (Yerkes Primate Center, Emory University, Atlanta, and Battelle Memorial Institute, Ohio) have overseen various components in the animal handling including vaccination, specimen collection, challenge and euthanasia. The Immunology Core lab of the Emory Vaccine Center is being utilized contractually to study the immunity response in both the human and animal studies, and aid the CDC in bridging data between the two parts. Modeling techniques will then be used to characterize the relationship between pre-challenge immune response parameters and outcomes after challenge. Data from this study will be used to support conclusions from the AVA human clinical study. In the past year, both the animal study and the human clinical trial have concluded. Analysis of the animal data is underway, and human data is being compiled and prepared for analysis.