| NB: Concepts represent early planning stages for PAs, RFAs, or RFPs for Council 's input. Council approval does not guarantee that a concept will become an initiative.
If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIH Funding Opportunities Relevant to NIAID.
Table of Contents
HIV Vaccine Design and Development Teams (HVDDT)
For the published initiative, see the June 8, 2007, solicitation.
Broad Agency Announcement
Contact: Josh LaVine
Phone: 1-866-410-5787 (Ext. 27149)
Internet: JLaVine@niaid.nih.gov
Objective: The objective of this program is to advance under-explored
promising vaccine concepts to the point where they can be evaluated clinically.
To this end we propose funding multidisciplinary teams comprised of
highly focused consortia of scientists with development experience
from industry
and/or academia that have (1) identified a promising vaccine concept
and (2) devised a plan for its targeted development into a product testable
in humans. It is expected that each team will have a different area(s)
of emphasis, performing comprehensive development and evaluation of a
specific, innovative, and currently under-explored vaccine concept(s).
The worldwide usefulness of the envisioned product is an important team
goal.
Description: This initiative will advance vaccine concepts into
the clinical testing stage by a focused, milestone-driven, product development-based
approach. Each team will assemble its own multidisciplinary cadre of
investigators guided by need, expertise, and commitment, rather than
by institution or corporation. Each team will focus on a specific vaccine
concept with particular emphasis on innovative and novel approaches,
culminating in a product that undergoes significant clinical evaluation.
Each team leader will be responsible for articulating and implementing
the strategic plan of the team. This will require well-formulated goals
and milestones that guide the evaluation and development of the vaccine
concept, and delineate how the vaccine concept will advance along the
development path. Teams will have the flexibility to reallocate resources
in a cost-effective manner to rapidly advance their vaccine concept.
Depending on the stage of development of the vaccine concept, the tasks
to be performed under the contract can change, expand or shrink based
on the team’s specific need and strategic plan, and could include
basic science, animal model development, production, IND-enabling studies
and documentation, and clinical research. Teams will be required to enter
vaccine products into clinical trials by the fifth year of funding, and
if results from those trials are promising the teams contract can be
extended up to an additional two years to enable optimization of the
vaccine and preparation for scale-up of manufacture for large-scale trials.
Synthesis of Therapeutic
Agents for Treatment of Infectious Diseases
For the published initiative, see the May 30, 2007, solicitation.
Request for Proposals
Contact: Anita Hughes
Phone: 301-496-0612
Internet: ah367o@nih.gov
Objective: This initiative will provide resources for the synthesis
of promising compounds for the treatment of HIV, opportunistic infections,
tuberculosis, hepatitis and other infectious diseases of relevance to
the research
agenda of
NIAID. Synthesis in support of microbicides screening and development
has been, and will continue to be, an integral part of this effort. The
synthesis and acquisition contract will synthesize chemicals in compliance
with current FDA Good Manufacturing Practice (GMP) regulations if necessary,
in quantities needed for testing in either in vitro screens, animals,
or early Phase I clinical studies. The initiative’s goal is to
further the development of promising compounds by providing resources
to investigators who have not identified a corporate sponsor so that
they might address specific, applied, and drug development issues.
Description: The Division of AIDS (DAIDS) supports research to
identify therapeutic agents for the prevention and treatment of infections
with the human immunodeficiency virus and opportunistic pathogens
associated with acquired immunodeficiency syndrome including Mycobacterium
tuberculosis. Researchers in these and other DAIDS-sponsored pre-clinical
programs are actively engaged in investigating the basic biology of the
targeted pathogens, identifying novel therapeutic approaches to treat
diseases caused by these infectious agents and testing therapeutic strategies
in animal models. In support of the DAIDS drug development effort, the
contract provides resynthesis of therapeutic reagents on small- and large-scale
amounts. For each compound synthesized the contractor provides: (a) a
summary of the synthetic process including scheme, all materials used
and amount, overall yield, solubility, etc.; (b) an analytical data sheet
that includes infrared, NMR, and ultraviolet spectra, melting point,
elemental analysis, chromatographic behavior, and when requested, MS
and/or 13C NMR; and (c) a Material Safety Data Sheet as required by the
Occupational Safety and Health Administration.
Novel HIV Therapies:
Integrated Preclinical/Clinical Program
For the published initiative, see the April
22, 2008, Guide announcement.
Request for Applications
Contact: Sandra Bridges
Phone: 301-496-8198
Internet: sb33j@nih.gov
Objective: The objectives of the Integrated Preclinical/Clinical
Program (IPCP) are to: (1) support innovative preclinical studies to
discover and develop new HIV therapeutics; and (2) drive the translation
of innovative treatment concepts from preclinical to pilot, clinical
proof-of-concept studies. Successful programs will develop a new treatment
concept that can be reduced to clinical practice and/or open a new research
direction.
Description: This initiative supports the discovery, development,
and evaluation of innovative concepts for the treatment of HIV infection.
The request for applications (RFA) is designed to foster preclinical
and clinical studies of promising therapeutic concepts through multi-disciplinary
research. In the preclinical area the RFA focuses on: (1) the development
and validation of new therapeutic targets; and (2) the discovery, development,
and evaluation
of small molecule inhibitors of viral or cellular proteins or pathways
critical to HIV replication. In the clinical area the focus is on iterative
bench to bedside research to optimize new therapeutic approaches. IPCP
applications may propose: (1) preclinical research exclusively; (2) preclinical
research that transitions to clinical research during the award period;
or (3) clinical research in the first year of award. To facilitate the
movement of new treatment concepts to the clinic, applications are required
to include at least one component (a research project or core) from the
private sector, e.g. a pharmaceutical or biotechnology company. Excluded
from the RFA is research on targets and approaches already under extensive
investigation, topical microbicides for HIV, non-targeted random screening
of potential inhibitors,
and research
on
AIDS-associated
opportunistic pathogens and malignancies.
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