B -- ANTHRAX VACCINE RESEARCH PROGRAM, HUMAN TRIAL STUDY

Notice Date

January 19, 2001

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146

ZIP Code

30341-4146

Solicitation Number

2001-N-00033

Response Due

March 7, 2001

Point of Contact

Lorenzo Falgiano, Contract Specialist, Phone (770) 488-2629, Fax (770) 488-2670, Email ljf5@cdc.gov -- Michael Detmer, Supervisory Contract Specialist, Phone (770) 488-2634, Fax (770) 488-2670, Email MDetmer@cdc.gov

E-Mail Address

Lorenzo Falgiano (ljf5@cdc.gov)

Description

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.

Web Link

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Record

Loren Data Corp. 20010123/BSOL003.HTM (D-019 SN50B3N0)