Foot and Mouth Disease (FMD) Vaccine Immune Response Study

The Department of Homeland Security (DHS), Science and Technology Directorate (S&T) has a requirement for "Foot and Mouth Disease (FMD) Vaccine Immune Response Study" entitled the "Evaluation of Antibody, Cellular and Innate Responses Following Adenovirus-Vectored FMD vaccine Administration." The main objectives of this effort are as follows: (a) Obtain and analyze FMD immune response data in domestic livestock that were administered an Adenovirus-vectored FMD adjuvant vaccine candidate: a. FMD antibody responses in swine, cattle, sheep and goats. b. FMD-specific cellular immune responses in cattle (e.g., T cell assays such as flow cytometry, ELISPOT, Th1 and Th2 cytokine profiling). c. Innate immune responses in cattle (e.g., TLR expression, pro-inflammatory cytokines, bovine innate immunity microarray). (b) Obtain and analyze FMD humoral immune response data in (3) FMD susceptible North American wildlife ruminant species that were administered an Adenovirus-vectored FMD adjuvant vaccine candidate: a. Elk (Cervus elaphus) b. White-tailed (Odocoileus virginianus) or mule (Odocoileus hemionus) deer c. Bison (Bison bison) (c) Evaluate the effect adenovirus-interfering antibody response in bovine adenovirus-seropositive cattle that were administered an Adenovirus-vectored FMD adjuvant vaccine candidate. (d) Perform an immunization study to assess mechanisms to enhance FMD antibody responses in cattle receiving an Adenovirus-vectored FMD adjuvant vaccine candidate using alternate vaccine delivery routes (e.g. s.c., intra-dermal, needle-free) To meet the objectives stated above the performer shall engage in: (a) Non-challenge, Adenovirus-vectored FMD adjuvant vaccine clinical studies in domestic livestock and wildlife species. (b) Laboratory analytical CMI and innate immune assays on collected cell/tissue samples. (c) Shipment of serum samples to DHS Plum Island Animal Disease Center (PIADC) for all antibody assays. (d) Statistical analysis of laboratory analytical data. (e) Submission of final study reports As a result, DHS Office of Procurement Operations (OPO) anticipates issuing a Request for Proposal (RFP), approximately 15 days after publication of this notice. This acquisition will be a Full and Open, Best Value competition, in accordance with Federal Acquisition Regulation (FAR) Part 15, Contracting by Negotiation. A cost reimbursable contract for an estimated 16 month period of performance is anticipated. This pre-solicitation notice is not to be construed as a formal solicitation nor is this an Invitation for Bid (IFB) or a Request for Proposal (RFP). The Government does not intend to award a contract on the basis of this notice. This notice is for information and planning purposes only. The Government will not provide reimbursement of costs associated with any documentation or communication submitted in response to this notice. Any submitted documentation, upon delivery, becomes the property of the U.S. Government and will not be returned. Questions or comments to this notice should be addressed to the Contracting Officer. DHS/OPO anticipates a single award during the 2nd quarter of the federal Government fiscal year 2011.