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 NIAID Funding Opportunities.
Table of Contents
Non-Biodefense Emerging
Infectious Diseases Research Opportunities
For the published initiative, see the March
6, 2007, Guide announcement.
Program Announcement
Contact: Kent Peters
Phone: 301/496-7728
Internet: petersn@niaid.nih.gov
Objective: To understand the natural history of microbial agents
of human infectious diseases and events leading to the acquisition of
pathogenic potential by non-biodefense pathogens.
Description: Research will focus on non-biodefense human pathogens
in non-pathogenic states, consortia environments, or non-human pathogens
prior to development of human pathogenic potential and on the changes
that result in human pathogenicity.
Some specific areas of interest include:
- Identifying animal viruses and other microbes that have a high potential
for becoming human pathogens.
- Understanding natural history of potentially
emerging pathogens; their natural means of variation, transmission,
and pathogenesis; the role of
reservoir vector hosts in microbial evolution leading to host switching;
and alterations in vector biology or behavior that favor transmission
of pathogens to human hosts.
- Understanding events surrounding pathogen
evolution by comprehensive sequence analysis before and after host-switching
events.
- Understanding the evolutionary and/or genomic changes associated
with cross-over of potential pathogens to ones causing human disease.
- Integrated
modeling that brings real world data and epidemiological analysis
to examine the spread of different types of microbes in different
hosts.
- Characterizing human microbial pathogens as they live in microbial
consortia. Research should focus on describing what microbes are present
in the consortia, the metabolism of the consortia, its physical structure
and interaction with the environment whether that environment is an
inanimate or living surface in association with the human host.
A Systems Biology Approach to Infectious Diseases
Research
For the published initiative, see the August
16, 2007, solicitation.
Broad Agency Announcement
Contact: Shamay Knox
Phone: 301/402-6990
Internet: sknox@mail.nih.gov
Objective: To apply a systems biology approach to better understand
infectious disease pathogens and their interactions with the host.
Description: Under this initiative, multidisciplinary teams with
expertise in microbiology, immunology, genomics, proteomics, bioinformatics,
and infectious diseases together with experts in mathematics, physics,
information technology, imaging science, and computer science will conduct
studies using the systems biology approach. A typical project for pathogen
systems biology would be organized around one or more driving biological
projects in microbiology and/or infectious disease that seamlessly integrates
experimental biology with computation and modeling.
The Centers will perform specific tasks in order to address biological
questions and take advantage of multidisciplinary teams. These centers
will emphasize the advantage of integrated yet varied expertise while
also taking advantage of data from previous and ongoing NIAID projects.
Typical components of each systems biology center may include:
- A functional genomics core which may include high-throughput gene
expression technologies, genotyping, and genetic variation discovery,
and genome-wide analysis of essential genes for predicting and identifying
functions and determining relevant phenotypes;
- A proteomics core, which may include high-throughput protein
production technologies; and
- An informatics core for data integration, analysis, and modeling
of biological systems.
Deliverables to the scientific community are expected to include integrated
data sets, tools, and technology as well as reanalyzed data from other
NIAID projects. Importantly, the infrastructure of the awarded Centers
will have the capacity for biological projects that will be focused on
the pathogen and its interaction with the host. It is predicted that
the interplay of the interacting parts of the system can be discovered
and provide a comprehensive understanding of how the components of a
system emerge into a complex system. In addition, developing and maintaining
a close interaction with the scientific community will be a necessary
component of this initiative and will include the rapid dissemination
of data, reagents, tools, and other resources generated.
Clinical Proteomics Centers for Infectious Diseases
and Biodefense
For the published initiative, see the August
2, 2007, solicitation.
Request for Proposals
Contact: Robert Singman
Phone: 301/451-2607
Internet: rsingman@niaid.nih.gov
Objective: To expand proteomics research resources, reagents,
and technologies with potential clinical application for monitoring susceptibility
and resistance to infection, early detection of infection, and therapeutic
and vaccine response.
Description: The initiative will involve the collection of relevant
clinical samples, protein biomarker discovery, target validation, and
analytical and bioinformatics tool development. In particular, the discovery
and validation of protein biomarkers for infectious diseases using well-defined
clinical samples will be supported. The Centers will be expected to carry
out the following functions:
- Identify collaborators with documented sources of well-defined
human clinical samples that can be utilized to foster the discovery
of potential biomarkers for infectious diseases.
- Develop procedures
and methods for sample preparation of human clinical samples for
use in proteomic analysis.
- Apply, augment, and/or develop
proteomic technologies and platforms for comprehensive and quantitative
protein profiling of biofluids (e.g., serum,
urine, sputum, and stool).
- Discover clinically useful pathogen
and host protein candidate biomarkers from well-defined human clinical
samples using high-throughput
protein purification and proteomic technology platforms developed for
comparative and quantitative protein profiling.
- Perform early
validation to confirm candidate protein biomarkers and their clinical
utility.
- Develop bioinformatic software and tools for clinical
proteomics to advance the discovery and validation of biomarkers
and technology
development.
Production of Monoclonal
Antibody-Based Therapeutics for Botulism
Broad Agency Announcement
Contact:Yvette Brown
Phone: 301/451-3686
Internet: ybrown@niaid.nih.gov
Objective: To develop monoclonal antibody-based therapeutics
against the botulinum neurotoxin serotypes A, B, and E for evaluation
in preclinical and early phase clinical studies.
Description: This initiative will provide resources for the development
of human compatible monoclonal antibodies with demonstrated in vivo activity
against the botulinum neurotoxins to a product that is suitable for evaluation
in humans. Specifically, this initiative will support development of
cGMP cell banks, manufacturing process development, cGMP manufacturing,
formulation, and preclinical evaluation for safety and activity.
Advanced Development of Multivalent Filovirus (Ebola
and Marburg) Hemorrhagic Fever Vaccines
For the published initiative, see the September 18, 2007, solicitation.
Broad Agency Announcement
Contact: Heidi Holley
Phone: 301/402-0641
Internet: holleyh@niaid.nih.gov
Objective: To conduct advanced product development activities
for multivalent vaccines for filovirus hemorrhagic fever virus.
Description: As the goal of this initiative is to obtain protection
against multiple viral strains, the development of multivalent vaccine
platform technologies such that one vaccine could protect against multiple
strains of Ebola and Marburg viruses will be sought. Activities to be
included in this initiative are:
- Prepare manufacturing, nonclinical, clinical, and regulatory development
plans.
- Appropriate preclinical IND enabling safety studies.
- Selection of candidate vaccines for pilot lot cGMP production
and subsequent Phase I and II clinical trials.
- Non-clinical
studies to organize dose, adjuvant (if applicable), and regimen to
enhance the level and duration of immunity.
- Development and validation of reagents and assays for preclinical
and clinical assays of protective immunity.
- Development
of manufacturing process and product release/characterization assays,
performance of necessary pilot and engineering runs,
and production and release of cGMP clinical lots for use
in Phase I
and II clinical
trials.
- Conduct of Phase I and II clinical trials.
Biodefense Vaccination Enhancement
For the published initiative, see the September 21, 2007, solicitation.
Broad Agency Announcement
Contact: Jordan Pulaski
Phone: 301/451-2569
Internet: jpulaski@niaid.nih.gov
Objective: To conduct advanced product development to integrate
novel product stabilization and antigen delivery technologies with biodefense
vaccines to significantly improve both product stability and vaccination
effectiveness.
Description: This initiative will support product development
activities for vaccines that address Category A or B Agents. Activities
to be supported will include the following:
- Development of manufacturing, non clinical, clinical, and regulatory
development plans.
- Development of pilot scale production processes.
- Conduct of comparative
preclinical safety evaluations.
- Conduct of product formulation and efficacy evaluations.
- Development,
characterization, and qualification of reagents, assays, and animal
models.
- Production of cGMP pilot lot(s) of candidate vaccine(s).
- IND submission(s).
- Conduct of Phase I and early Phase II clinical
trials.
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