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 VACCINES FOR CLINICAL TRIALS SOL n/a DUE 032098 POC Frederick R. Vogel, (301) 435-3747, Fax (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 two HIV vaccine reagents. These are: 1) an intact virion HIV containing an NSI env protein, that is genetically incapable of replication (i.e., a "pseudovirion"). 2) HIV env proteins from primary isolates (NSI or dual-tropic) produced in mammalian expression vectors. Since these products 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, these products must be manufactured under cGMP conditions. 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 components for use in nonhuman primate studies as well as in clinical trials in combination with other vaccines. Interested firms must document their past experience and technical expertise in each of the above areas. This is not a Request for Proposal (RFP). NO RFP is available and DAIDS is not committed to award a subcontract 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 March 31, 1998 to Frederick R. Vogel, Vaccine and Prevention Research Program, DAIDS/NIAID, 6003 Executive Blvd., Rm. 2A-02, Rockville, MD 20852, Tel. (301) 435-3747, Fax. (301) 402-3684, E-mail fv1v@nih.gov. (0071)

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