National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- HIV VACCINE DESIGN AND DEVELOPMENT TEAMS (HVDDT) SOL NIH-NIAID-DAIDS-00-10 DUE 063099 POC Mr. Paul D. McFarlane, Contracting Officer, 301-496-0349 The Division of Autoimmune Deficiency (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has a requirement for the development of an efficacious vaccine against HIV for worldwide use in stemming the AIDS epidemic. While industry, government and academia have all targeted considerable resources to this end over the past 15 years; identification of an efficacious vaccine against HIV/AIDS has yet to be accomplished. A wide assortment of candidate HIV-1 vaccines has already been pursued and many have reached the stage of safety and immunogenicity testing in humans. However, only one vaccine efficacy trial has been initiated, and a second efficacy trial is unlikely to begin before 2000-2001. At this time the highest priority of the Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH, is the discovery, development, and evaluation of HIV/AIDS vaccines. To augment the vaccine product pipeline, we are seeking opportunitiesto advance vaccine concepts toward the product stage via a focused, development-based approach. Specifically, the long-range goal of this solicitation is the development of new safe and immunogenic vaccine candidates that merit further evaluation in larger human trials. The HIV Vaccine Design and Development Teams (HVDDT) solicitation seeks to fund consortia of scientists with development experience from industry and/or academia that have 1) identified a promising vaccine concept, and 2) envisioned a product worthy of targeted development. A vaccine product is defined here to be a material and its manner of administration that could reasonably provide protection against AIDS. Offerors are encouraged, but not required to conduct phase I/II trials in collaboration with NIAID/DAIDS-supported HIV/AIDS vaccine trials networks. Support for Phase III studies will not be funded under this solicitation. The expectation will be that the Teams advance their vaccine concepts along a well-defined development path in a timely manner toward a vaccine product within the five year period of the award. Because the goal of this effort is the development of vaccine products, each Team will be required to demonstrate proven scientific and development expertise, and provide a comprehensive plan that lays out clearly defined objectives and milestones for the project's duration. Because the design and development path for a vaccine product cannot be entirely anticipated, the Team must articulate its vision of how new scientific findings will be integrated into the existing goals and milestones. Offerors will be required to articulate and implement a strategic research plan that includes: (a) key development objectives and a detailed work plan describing proposed time schedules for achieving contract objectives and milestones, and maintaining quality control over the implementation and operation of the contract; (b) how decisions to proceed or not proceed will be made including decisions to proceed or not proceed vis a vis human safety, immunogenicity, and testing; and (c) plans for GMP vaccine lot production and obtaining the necessary government and ethical approvals to proceed. Integrated into this strategic plan should be the articulation of how the Teams will efficiently allocate and utilize the resources, redirect the focus (including reallocation of funds), depending upon the project's changing needs and emerging new knowledge; and obtain patent coverage and licensing of the resulting HIV vaccine, and procedures to be followed for the resolution of potential legal issues that may arise. RFP NIH-NIAID-DAIDS-00-10 will be available electronically on or about January 28, 1999, and may be accessed through the NIAID Contract Management Branch (CMB) Homepage by using the following electronic address and instructions: NIAID-CMB Homepage (via the World Wide Web): access by: http://www.niaid.nih.gov/contract and select the "RFPs" link. Please note that the RFP for this acquisition has been revised to include only the Research and TechnicalObjectives, deliverable and reporting requirements, special requirements, and mandatory qualifications, if any, the Technical Evaluation Criteria, and the proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and review, offerors may be requested to provide additional documentation to the Contracting Officer. Proposals in response to this RFP will be due on or about June 30, 1999. Any responsible offeror may submit a proposal, which will be considered by the Government. This advertisement does not commit the Government to award a contract. It is anticipated that up to five (5) cost-reimbursement contracts will be awarded for a maximum period of five (5) years each. Point of Contact: Paul D. McFarlane, Contracting Officer Electronic Mail Address: pm24v@nih.gov Telephone: (301) 496-0349 Telefax: (301) 402-0972 No collect calls will be accepted!! Posted 01/25/99 (W-SN291130). (0025)

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