National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- CANDIDATE HIV RECOMBINANT CORE VACCINE FOR CLINICAL TRIALS DUE 092597 POC Frederick R. Vogel, (301) 402-3684, E-MAIL: fvlv@nih.gov The Division of AIDS (DAIDS), NIAID, NIH is conducting a market survey to determine the availability and capability of developers of a candidate HIV-1 p55 Gag vaccine. This product should be produced as a particle that does not package or contain a complete HIV-1 genome. This vaccine is to be used in clinical testing in humans, therefore the supplied product must be manufactured under cGMP conditions. This product will be considered for Phase I clinical trials alone and in combination with other vaccine products and may eventually be considered for larger-scale clinical trials. To be considered, developers must: (1) have an existing relationship with (or be) a manufacturer with experience in producing HIV candidate vaccines meeting FDA standards for use in human studies involving healthy volunteers; (2) have experience with recombinant protein HIV vaccines; and (3) be willing to supply the candidate vaccine for use in nonhuman primate studies and in clinical trials of the p55 Gag vaccine antigen in combination with other vaccines. Interested firms must document their past experience and technical expertise in each of the above areas. Selected developer(s) will be asked to develop one or more candidate HIV vaccines for safety and immunogenicity testing, possibly including vaccines for HIV subtypes other than clade B. This is not a Request for Proposal (RFP). NO RFP is available and DAIDS is not committed to make an award pursuant to this announcement. Interested firms should furnish 5 copies of their capability information addressing the three (3) areas cited above, no later than 4:30 p.m. local time on September 25, 1997 to Frederick R. Vogel, Vaccine and Prevention Research Program, DAIDS/NIAID, 6003 Executive Blvd., Rm. 2A28A, Rockville, MD 20852, Tel. (301) 435-3747, Fax. (301) 402-3684, E-mail fv1v@nih.gov. (0246)

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