Support for Research on Retroviral Pathogenesis, Treatment, and Prevention

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.TITLE: Support for Research on Retroviral Pathogenesis, Treatment, and PreventionThe Vaccine Branch (VB) in the Division of Center for Cancer Research (CRC) of the National Cancer Institute (NCI) is recompeting a full and open contract for support services for research on retroviral pathogenesis, treatment, and prevention.A key area of investigation in the VB involves retroviruses, particularly human immunodeficiency virus (HIV), the causative agent of acquired immune deficiency syndrome (AIDS), and Simian Immunodeficiency Virus (SIV), the related monkey virus which provides a model for detailed experimental investigations. Other viruses are studied as well, including Human T cell leukemia lymphoma virus (HTLV-1/2) and viruses used as vaccine vectors. Vaccine approaches are a major area of study; however, investigations of viral pathogenesis and treatment are also on-going. Previous

contracts have provided critical support to these endeavors. Contract activities have included provision of retroviruses, purified retroviral and cellular proteins, polyclonal and monoclonal antibodies and cell culture support; and performance of immunologic assays and assays to assess the virological status of cells and tissues in vivo and in vitro. The proposed project will continue to provide support for major programs of the VB, and will include support activities related to work on vaccines for prevention of retroviral infection, treatment strategies for AIDS, and elucidation of mechanisms of retroviral pathogenesis.The proposed contract will continue to provide research support for major research programs of the VB, and will include support activities related to development of vaccines for prevention of retroviral infection, development of treatment strategies for AIDS, and elucidation of mechanisms of retroviral pathogenesis.The scope of this proposed contract is to provide ongoing services in areas including cell culture and virology, immunology, protein biochemistry, molecular biology, storage of biological material and pick up/delivery of specimens for the Vaccine Branch, Center for Cancer Research, of the National Cancer Institute, Bethesda, Maryland.Some of the major activities of the contractor include:Option A - Transition In: Ensure a smooth transition between the incumbent contract and the new award without a break in services. Transfer relevant files, records, materials, and data; use an appropriately bonded moving agent experienced in secure transfer of biological material; ensure adequate computer service and data storage is available and storage of biological samples at appropriate temperatures.Core work:Accomplish the following:A. Pickup and delivery of Biological specimens:The Contractor shall arrange for pick-up and delivery of specimens, Monday through Friday, except Government holidays, between the Contractor's site and laboratories on the NIH main campus or NCI Fort Detrick campus.The Contractor shall also arrange shipment of specimens or reagents to outside investigators as requested by the COR. The Contractor shall package biological specimens according to U.S. Department of Transportation regulations http://www.who.int/csr/emc97_3.pdf which describes the packaging and transportation. The packing materials must be of good quality and strong enough to withstand leakage, pressure, vibration, temperature changes, conveyor and mechanical conditions.The Contractor is responsible for shipping and packing of the materials after the work has been performed. The Investigator's lab will supply their own packing materials when the items are ready to be sent the Contractor. Packing materials such as Styrofoam boxes, freezer storage cardboard boxes, or Saf-T-Pak shipping boxes are acceptable containers for the Contractor to use for delivery of materials. The shipping items shall be saved for reuse as to cut down on cost.B. Immunological assays and reagent preparation:1. Conduct serological assays of human or animal samples supplied by NIH. Serum or plasma samples provided by the Government shall be tested for the presence of antibodies to human and other mammalian viral proteins or peptides (HIV, SIV, HTLV-1/2) using such techniques as ELISA, Western blot, and antigen capture assays. Pepscan assays shall be conducted to determine specific antibody epitopes recognized and ELISAs shall be conducted to determine antibody titers and isotypes.2. Provide purified, biochemically characterized and biologically active (where appropriate) native viral proteins from infected cells or conditioned media and from bacterial or mammalian expression systems.3. Provide between three (3) and six (6) sets of overlapping peptides, representing proteins from the HIV, SIV, or adenovirus genomes.4. Provide purified monoclonal antibodies by expressing antibody genes provided by the government in 293 T-cells by transfection or by producing stable CHO cell lines and purifying the antibody in quantities up to 2 grams.5. Carry out assays measuring the ability of sera or purified antibody to inhibit virus propagation by virus reduction assay.6. Provide CD4/CD8 and B cell counts (percentages and absolute numbers) from 500 to 1500 blood samples per year from non-human primates.C. Viral stock preparation and virological assays:1. Provide between one (1) and four (4) purified and titered stocks of attenuated recombinant poxviruses or recombinant TK- vaccinia with titers of 10^9 to 10^10 TCID50/ml as requested by the COR. The TK- vaccinia recombinants must be expanded under BL2 conditions. Quality control for the expression of heterologous HIV/SIV genes should be provided by Western Blot.2. Provide between two (2) and ten (10) titered stocks of aliquots of field isolates for in vitro use from virus-infected humans and non-human rimates at low passage number on human or non-human primate PBMC. The stocks shall be of sufficient titer for in vitro experimentation (10^4 to 10^5 TCID50/ml). Determine titer by plaque assay and provide aliquots of high-titered T-cell-line-adapted (TCLA) stocks of HIV or SIV for in vitro use.3. Expand and purify replication-competent Adenovirus stocks provided by the Government, to 2 to 3 ml with a titer of 10^10 - 10^11 plaque forming units/ml. Titers shall be determined by OD and by plaque assay. For the purified Adenovirus stock, the ratio of the OD titer to the titer by plaque assay shall be no more than 30.4. Conduct real time PCR assays for SIV gag in plasma and SIV gag in tissues. Purify and quantitate mRNA in plasma or tissue samples of animals or humans by real time PCR. Conduct assays to quantitate viral DNA levels by real time PCR for SIV from cells of non-human primates.D. General molecular assays and regent preparation:1. Synthesize and purify codon-optimized genes encoding cellular or viral proteins designed by the Government for eukaryotic or prokaryotic expression. For the individual genes produced, the Contractor shall provide up to 2-50 mg of DNA.2. Provide pre-clinical grade plasmid DNA (up to 50 mg per preparation) containing minimal levels of endotoxin and encoding HIV or SIV genes.E. Storage of biological materials:Provide storage and electronic inventory for viable cell lines, titered field isolates, viral challenge stocks and viable cell specimens from inoculated and immunized animals as requested by the COR. The Contractor shall maintain a backup system capable of maintaining materials stored at the required temperatures. The storage capacities and temperature requirements are:1) cubic feet of minus 180 degrees Celsius storage maintained by liquid nitrogen,2) 185 cubic feet of minus 80 degrees Celsius storage, and3) 75 cubic feet of minus 20 degrees Celsius storage.F. Option B - Transition outPlan and coordinate an orderly, secure, and efficient transition of all activities, materials, data, and other documents to the successor Contractor or the Government. A description of transition activities and timelines shall be provided in a Draft and Final Transition Plan, which shall be reviewed and approved by the COR and Contracting Officer.G. Option C - Option to Extend the Term of the ContractTo extend the term of the contract for up to 6 months. MANDATORY QUALIFICATION CRITERIAThe Mandatory Qualification Criteria establish conditions that must be met at the time of initial proposal submission as determined by the Contracting Officer for your proposal to be considered any further for award. The following Mandatory Qualification Criteria apply to this solicitation:1. Must have biocontainment facilities with Biosafety level (BSL) 2 with Biosafety level (BSL3) practices to conduct work with human retroviruses and non-human primate retroviruses (HIV, SIV, SHIV, HTLV-1/2), adenovirus, and poxviruses. The offeror is required to provide a certification of BSL 2 with a BSL 3 at the time of proposal submission.2. Must be able to supply fresh, viable cells and biologically active purified proteins to the Government within one hour after harvest or preparation. The offeror is required to provide their address and distance from the NIH Campus located at 9000 Rockville Pike, Bethesda, MD 20892-1360 and NCI Fort Detrick Campus located at 810 Schredier Street #1, Frederick, MD 21702. The offeror must be within one hour from both NIH campus locations.The services will be acquired through full and open competition. It is anticipated that one (1) cost-reimbursement type contract will be awarded as a result of the solicitation with a base period of one (1) year plus four (4) additional one-year option periods beginning on or about June 1, 2018.The RFP will be available electronically on or about November 27, 2017 and may be accessed through the FedBizOpps at www.fbo.gov. We encourage all responsible sources, particularly small businesses, to submit a proposal, which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS' RESPONSIBILITY TO MONITOR THE ABOVE INTERNET SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.