Release Date:  February 4, 1999



National Institute of Allergy and Infectious Diseases

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 opportunities to 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:
and select the 'RFPs' link.

Please note that the RFP for this acquisition has been revised to include only
the Research and Technical Objectives, 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
Telephone:  (301) 496-0349
FAX:  (301) 402-0972

No collect calls will be accepted

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