This is Classification Code: A - Research & Development

NAICS Code: 541 - Professional, Scientific, and Technical Services/541711
- Research and Development in Biotechnology

RFP No. DVC0065-PLAG-09; Set Side - Preference given to Small Businesses, SD-VO, Hub-Zone but it not considered a set-aside.

The RFP closing date is August 6th 2009.

DynPort Vaccine Company LLC, a CSC company (DVC) is the prime systems contractor for the U.S. Department of Defense Joint Vaccine Acquisition Program (JVAP) and is responsible for the advanced development and licensure with the Food and Drug Administration (FDA) of vaccines and other biological products designed to protect against a variety of biological agents.

As part of this program, a recombinant vaccine for protection against pneumonic plague is undergoing advanced development by DVC. The antigenic component of this vaccine is a single protein produced from a fusion of the Yersinia pestis genes for the F1 capsular protein and the V virulence protein. The product is currently being investigated in the U.S. under a DVC sponsored IND. As the efficacy of this vaccine cannot be tested in humans, it is essential to develop in vivo and in vitro surrogate assays that are valid predictors of immunity.

An assay was developed at USAMRIID based upon the observation that infection of macrophage cultures with Yersinia. pestis (Y. pestis) leads to
apoptotic cell death. This cytotoxicity activity may be inhibited with
immune serum. The functional activity of immune sera obtained from
vaccinated mice was tested in macrophages infected with Y. pestis or Y.
pseduotuberculosis. Results using microtiter-based assays with adherent
murine-derived macrophages, using the caspase-3 assay of apoptotic cell death, provided a good in vitro correlate of protective immunity in proof-of-concept studies conducted with the serum from rF1V vaccinated
mice. The macrophage cytotoxicity neutralizing activity (CyNA) of anti-V
antibodies present in the rF1V immunized mouse sera correlated with
protective immunity to lethal challenge with Y. pestis. To further
demonstrate the extent of correlation between in vitro protection against cytotoxic infection and survival from aerosol challenge, serum collected from rF1V vaccinated cynomolgus macaques was also successfully evaluated in the assay. This assay has been selected for further development and use as an in vitro correlate assay of protection of rF1V-vaccinated humans.

DVC is seeking the technical services for the assay technology transfer, method optimization, qualification and validation. The technical services are also required for the testing of nonclinical and/or clinical sera samples for cytotoxicity neutralizing activity.

If you are interested in receiving a copy of this solicitation, please
contact: Jo Ann Brown, Principal Subcontract Administrator, DVC, LLC, a
CSC company at [email protected]

Please only contact the person noted above and not the USASMDC office listed in this announcement.

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