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Anthrax Vaccine Research Program, Human Trial Study

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Anthrax Vaccine Research Program, Human Trial Study Primary Sponsor: Centers for Disease Control Deadline: 3/7/2001 KEYWORDS COMMERCE BUSINESS DAILY ISSUE OF JANUARY 23,2001 PSA#2772 SOL 2001-N-00033 DUE 030701 POC Lorenzo Falgiano, Contract Specialist, Phone (770) 488-2629, Fax (770) 488-2670 The Centers for Disease Control and Prevention (CDC) contemplates a single award, to conduct a human reactogenicity and immununogenicity trial, to address a change in the route of administration and dose reduction of the anthrax vaccine. The award of this contract will complete a larger, multi-site study currently being conducted by CDC. The addition of another study site to the sites already in place, will bring the additional human subjects and data needed to validate the anticipated study results. The CDC has been tasked by Congress to study the safety and efficacy of vaccines used against biological agents. Specifically, to determine if these studies will support changes in the route of vaccine administration and reduce the number of doses in the currently recommended anthrax vaccination series. The multi-site studies will specifically address (1) the risk factors for adverse events between men and women; (2) determining immunological correlates of protection and documenting vaccine efficacy, and (3) optimizing the vaccination schedule and administration to assure efficacy while minimizing the number of doses required and the occurrence of adverse events. Additional information surrounding human immunologic research is needed to specifically address items (2) and (3) above, and the data from these studies will serve as a scientific basis for discussions regarding the development of new vaccines for anthrax. The period of performance for this study will be approximately sixty (60) months and will be incrementally funded based upon the government's need and availability of funds. The schedule issue date of the solicitation is approximately February 5, 2001. No telephone requests will be accepted; only written requests for this solicitation will be honored. Requests should cite RFP number 2001-N-00033 and may be mailed to the address on this notice, faxed or e-mailed. All responsible sources that meet the government's requirements may submit a proposal which will be considered by the Agency. Email ljf5@cdc.gov -- Michael Detmer, Supervisory Contract Specialist, Phone (770) 488-2634, Fax (770) 488-2670, Email MDetmer@cdc.gov. Posted 01/19/01 (D-SN50B3N0). (0019)