National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Room 2230, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD 20892-7612

A -- REQUEST FOR CAPABILITY STATEMENTS DUE 050200 POC Lawrence M. Butler, Contracting Officer Ph: 301-496-0192 FAX: 301-402-0972 E-MAIL: Lawrence M. Butler, lb13t@nih.gov. The Division of Microbiology and Infectious Diseases (DMID), NIAID, NIH is conducting a market survey to determine the availability and capability of offerors able to rapidly and efficiently undertake expanded Phase II, Phase III and Phase IV vaccine immunogenicity and safety evaluation clinical trials on investigational and licensed monovalent and combination vaccines. The capacity to evaluate new and improved vaccine candidates in an efficient and expeditious manner is an essential element of the efforts of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID). With the rapid development of new and combination vaccines, the Government has an increased need for capacity to clinically evaluate these products for safety and immunogenicity (Phase II trials). There is also a potential need for Phase III and Phase IV trials. When the need arises, the offeror would be expected to 1) Provide facilities and staff necessary to conduct expanded Phase II, Phase III and Phase IV prophylactic and therapeutic studies on candidate vaccines in human volunteers. 2) Provide subjects from appropriate populations as required for the Phase II, Phase III and Phase IV clinical evaluation of licensed and investigational monovalent and combination vaccines. The target populations for these vaccines include infants, children, adults and the elderly. 3) Determine vaccine safety, immunogenicity, reactogenicity, optimal dose and schedule, depending on the vaccine being tested, using Phase II, Phase III and/or Phase IV clinical trials. Collect and appropriately store sera and other body fluids from study participants. Conduct appropriate immunologic assays to determine volunteer eligibility, baseline levels on entry into a study, and response to the candidate vaccine(s). Follow vaccinees for up to three years to document duration of antibody or immune response, resistance to infection in the event of natural challenge within the community, and potential hazardsof immunization. This is not a Request for Proposal (RFP). No RFP is available and DMID is not committed to make an award pursuant to this announcement. Interested offerors should furnish two copies of their capability information addressing the three areas cited above. No collect calls will be accepted. See Numbered Note 25. Posted 04/18/00 (W-SN446018). (0109)

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