This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and an additional written solicitation will not be issued. The U. S. Army RDECOM Contracting Center, Natick Contracting Division, Natick, MA on behalf of the Naval Medical Research Center (NMRC) has a requirement for the acquisition of H1N1 vaccine. The Government anticipates one FFP award, however it reserves the right to make multiple awards or no award. The contractor will produce and vial Good Manufacturing Process pDNA using the VCL-10551 plasmid that encodes swine-origin influenza virus (SOIV) strain A/California/04/09 (H1N1) hemagglutin (H1 pDNA). Test lots of the pDNA must be adjuvanted with Vaxfectin and tested in mice and rabbits using needle and syringe delivery and demonstrate immunogenicity in both species via a hemmagglutin inhibition assay. The contractor must prepare and submit an IND application for a H1 pDNA-Vaxfectin vaccine to the FDA and must agree to serve as the sponsor of a Phase I clinical trial in humans. The contractor must also develop an immunoassay to evaluate human clinical samples. The reason that both Vaxfectin(r) and VCL-10551 must be used is that they have already shown safety, tolerability and immunogenicity in animals and humans in an H5 influenza vaccine under an Investigational New Drug (IND) Phase I clinical trial by standard needle and syringe delivery methods. Vaxfectin(r) has also been shown to enhance immune responses in other DNA vaccines. Therefore, the purpose of the work to be performed under this contract is to rapidly produce a novel H1 DNA-Vaxfectin vaccine and IND for the purpose of assessing safety, tolerability and immunogenicity in a Phase I clinical trial. The potential total contract value is estimated $1,250,000 over a one year period. The estimated start date is September 2009. This procurement is a 100% small business set aside under NAICS code 325414. The small business size standard for this procurement is a firm with average monthly employee count, including all affiliates, for the last 12 months not in excess of 500 employees. The Request-For-Proposals (RFP)is attached to this announcement. Although the attached RFP states that proposals must be received by 08/15/2009, offerors have UNTIL 02:00 PM EST ON MONDAY, 08/17/2009 to submit proposals; proposals should be submitted electronically via email to [email protected]. Proposals received after 02:00 PM EST ON MONDAY, 08/17/2009 will not be considered. Any questions must be sent via e-mail to [email protected]. No phone calls or FAXes will be accepted. The acquisition is utilizing Federal Acquisition Regulation (FAR) Parts 12 and 13.

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