RFP ANNOUNCEMENT: HLA TYPING AND EPITOPE MAPPING RELATIVE TO HIV VACCINE DESIGN - NIH-NIAID-DAIDS-03-13 Release Date: June 5, 2002 NOTICE: NOT-AI-02-025 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Receipt Date: September 16, 2002 DESCRIPTION The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports a comprehensive portfolio of grant and contract resources to discover, develop and test potential vaccines to prevent and treat infections caused by Human Immunodeficiency Virus-1 (HIV-1). The purpose of this contract is to support acquisition of specific datasets by studying the immune responses of individuals infected with non-clade B HIV-1 at one or more international location(s). These datasets include: a) DNA-based molecular HLA class I and II typing of selected HIV seropositive and seronegative populations at existing or proposed international vaccine trial sites; b) characterization of cellular immune responses and the mapping of CTL epitopes and helper epitopes that are restricted by common HLA types; c) measurement of neutralizing antibody responses; d) identification, characterization and sequencing of circulating HIV-clade variants; and e) establishment of a database of HLA-types, associated T cell epitopes, antibody responses, and viral variants. The "HLA Typing and Epitope Mapping to Guide Vaccine Design" initiative was first competed in 2000. This competition attracted a high level of interest and quality of Offerors. One award, N01-AI-15442, with Massachusetts General Hospital was instituted in May 2001. The emphasis in N01-AI-15442 is measuring HIV-specific T cell immune responses and performing viral sequencing in HIV-1 clade B-infected non-Caucasian populations in the Americas, and in non clade-B infected populations in South Africa. The purpose of this initiative is to expand acquisition of the datasets described above into additional, new, international sites. The clinical research organization must: 1) Establish a research and administrative team that includes all expertise needed to: select and acquire HIV+ and HIV- human specimens; perform DNA-based molecular HLA class I and II typing in selected seropositive and seronegative populations; perform an array of immunologic assays, in particular CD8+ and CD4+ T lymphocyte cellular assays; identify CTL and immunodominant T helper epitopes and their respective HLA-restricting elements in HIV-infected individuals; measure neutralizing antibody responses in HIV-infected people; perform sequence analysis of the HIV viral variants in the geographic location(s) of the cohorts to be vaccinated; and establish a database of the acquired immunogenetic, immunologic and virologic information. 2) Select, secure, receive, catalog, process and store samples from uninfected and HIV-infected individuals at international sites that are very likely to conduct future HIV-1 vaccine trials. Sampling may include: whole blood, viably cryopreserved blood mononuclear cells, serum, other tissues or body fluids, and virus culture supernatants from. The Contractor shall arrange for samples to be shipped from the supplier directly to the Contractor or to a central sample processing facility. The handling and transportation of all samples under this contract shall be in accordance with all applicable local, state, Federal and international regulations including health and safety standards. It is anticipated that the period of performance for this contract will be a total of five (5) years beginning on or about 05/08/2003. Any responsible Offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. RFP-NIH-NIAID-DAIDS-03-13 will be available electronically on or about May 30, 2002, may be accessed through the NIAID Contract Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract and will be posted on FedBizOpps. Contracting Office Address: National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact: Scott Drega Contract Specialist Phone 301-496-6424 Fax 301-480-5253 Email sd222q@nih.gov Paul D. McFarlane Senior Contracting Officer Phone 301-496-0349 Fax 301-402-0972 Email pm24v@nih.gov This announcement does not commit the Government to award a contract. No collect calls will be accepted.
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