September
2009 DAIT Council-Approved Concepts
NB: Concepts represent early planning stages for PAs, RFAs, or solicitations 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
Asthma and Allergic Diseases Cooperative Research Centers
Request for Applications
Contact: Gang Dong
Phone: 301-594-8153
Email: gdong@niaid.nih.gov
Objective: With the rising prevalence of asthma and allergic diseases worldwide, this program aims to promote innovative, multidisciplinary, and translational research on asthma and allergic diseases. The program's overarching goal is to improve the diagnosis and treatment of asthma and allergic diseases and to provide a strong scientific foundation for the development of effective prevention strategies.
Description: The initiative will support NIAID's unique and long-standing Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program, which funds research centers across the U.S. to conduct interdisciplinary and translational research in asthma and allergic diseases. The centers coordinate their efforts through a steering committee and collaborate with one another through a discretionary fund that supports small, independent pilot studies.
This is a renewal initiative and no substantial change in the scope is anticipated.
Genomics of Transplantation
Request for Applications
Contact: Nasrin Nabavi
Phone: 301-435-3567
Email: nnabavi@niaid.nih.gov
Objective: The long-term goal of the Genomics of Transplantation Cooperative Research Program (GTCRP) is to understand the genetic basis of immune-mediated graft rejection and differences in transplant outcome, and thereby provide a rationale for the design and development of effective treatment and prevention strategies to improve long-term graft survival and better quality of life for transplant recipients. This concept clearance is for a competitive renewal of the GTCRP.
The program specifically will identify and characterize gene polymorphisms and expression patterns that correlate with and predict differences in:
- Responses to specific immunosuppressive therapeutics.
- Transplant graft survival and rejection.
- Immune responses during acute and chronic graft rejection that relate to onset and severity.
Description: This initiative will support a cooperative network of investigators from diverse backgrounds, including molecular biologists, population geneticists, immunologists, transplant clinicians, statisticians, and informatics specialists to conduct research directed at:
- Pharmacogenetic analysis of microsatellite and single nucleotide polymorphisms (SNPs), as well as SNP haplotypes in candidate genes of both transplant donors and recipients, and correlation of these genetic variations with responses to, and outcomes of, immunosuppressive protocols.
- Delineation of microsatellite polymorphisms, SNPs, and SNP haplotypes in candidate genes and identify unique gene expression patterns in minority populations who are at risk of lower graft survival.
- Analysis of gene polymorphisms, cDNA microarrays, as well as proteomics to identify and characterize immune response genes expressed during acute and chronic graft rejection, that relate to onset and severity of graft rejection.
- Statistical and database approaches to analyze multiple gene interactions.
These studies will utilize recipient and donor blood and tissue samples, as well as clinical information, from both retrospective and concurrent clinical trials in transplantation.
NHP Transplantation Tolerance Cooperative Study Group: Opportunities Pool Expansion
Request for Applications
Contact: Kristy Kraemer
Phone: 301-496-0982
Email: kkraemer@niaid.nih.gov
Objective: The goal of the Nonhuman Primate Transplantation Cooperative Study Group (NHPCSG) is to evaluate the safety and efficacy of novel tolerance-induction therapies in NHP models of kidney, islet, heart, and lung transplantation. In addition, the program supports research into the immunological mechanisms of tolerance induction and development of surrogate markers for induction, maintenance, and loss of tolerance.
Description: While the NHPCSG has many promising therapeutic strategies under study and in development, an opportunities pool (discretionary fund) allows newly identified tolerance-inducing therapeutics and strategies to be developed and evaluated in a timely manner prior to the conduct of clinical trials. The NHPCSG has a discretionary fund for pilot projects in islet and kidney models that is supported by the Congressional Special Appropriation for Type 1 Diabetes program. This additional funding for the discretionary fund will allow similar pilot projects using heart and lung models. This initiative also provides an opportunity for critical pre-clinical research to complement NIAID-supported transplantation clinical trials. Proposals for new projects undergo competitive review within the NHPCSG as determined by the NHPCSG steering committee. The emphasis will be on the funding of collaborative projects and newly emerging opportunities.
Nonhuman Primate MHC Gene Discovery and Typing Technology Development
Broad Agency Announcement
Contact: Deborah Blyveis
Phone: 301-594-7211
Email: blyveisd@niaid.nih.gov
Objective: To renew support of the Nonhuman Primate Major Histocompatibility Complex (MHC) Gene Discovery and Typing Technology Development program. The program's goal is to accelerate immunological research in nonhuman primate (NHP) models of vaccine and adjuvant development, infectious and immune-mediated diseases, and transplantation by 1) defining MHC alleles in multiple NHP species and 2) developing technologies for rapid high-throughput MHC typing.
Description: This initiative is a competitive renewal of the NHP MHC Discovery and Technology Development Program. It has three components: 1) gene identification and sequencing of the classical MHC loci and alleles in the most studied NHP species, 2) development of rapid, high-throughput MHC typing methods that can be easily adapted or utilized by NHP research laboratories, and 3) provision of MHC allele sequences, frequencies, and primers/probes required for typing or discovery to the NHP research community.
NIAID Division of Allergy, Immunology, and Transplantation: Regulatory Management Center
Request for Proposals
Contact: Albert Nguyen
Phone: 301-451-2610
Email: nguyenal@mail.nih.gov
Objective: To provide DAIT's Office of Regulatory Affairs with regulatory and good clinical practice (GCP) compliance support for network and non-network trials that the Division supports. The scope of this contract will cover all trials whether conducted under health authority application or not. The centralized regulatory support initiative will facilitate the Division's ability to fulfill its responsibilities as a clinical trials sponsor to ensure: the safety and welfare of participants; adherence to applicable regulations, policies, standard procedures, required guidelines, and study protocols; and harmonization of processes across DAIT branches and programs to remove unnecessary redundancies of operations that will lead to ultimate cost savings.
Description: The Regulatory Management Center will support DAIT's Office of Regulatory Affairs in activities required for conducting DAIT- supported clinical trials (including network- and consortia-conducted trials as well as investigator-initiated U01 trials) in the U.S. and elsewhere. Activities will include:
- Regulatory and Good Clinical Practice (GCP) Compliance
Assemble and submit regulatory documents required by health authorities overseeing the specific clinical trial. Submissions may be in paper as well as electronic format.
Maintain electronic and hard copy files of all correspondence and submissions to regulatory health authorities for DAIT-sponsored clinical trials.
- Electronic Tracking of IND Safety Reports
Establish and maintain an electronic system for tracking and reporting IND safety reports (serious adverse events) for all DAIT-sponsored clinical trials to the FDA and other regulatory authorities, DAIT, pharmaceutical companies, and investigators.
- Electronic Clinical Site Registration System
Develop and maintain an electronic clinical site registration system for all trials (whether or not conducted under a health authority application) that tracks all site documents required before initiating a trial at the site.
The expansion of this contract is to include any DAIT-sponsored trial. Additional funds will be requested.
Protective Immunity in Special Populations
Broad Agency Announcement
Contact: George Ralis
Phone: 301-496-0194
Email: ralisg@mail.nih.gov
Objective: The scientific objectives of this initiative are: 1) characterizing immunological defects responsible for insufficient host response to infection, vaccination, or immunotherapy against one or more emerging/re-merging infectious disease, including NIAID Category A, B, and C priority pathogens in immune compromised populations and 2) conducting mechanistic studies to determine how the identified defects alter host responses to infection, vaccination, or immunotherapy in these individuals.
Description: This program will support contracts that characterize the immune response in immunocompromised groups and conduct mechanistic studies to determine how immune defects alter generation and maintenance of protective immunity to infection or vaccination. Proposals will utilize in vitro methods using human cells and appropriate in vivo animal models to conduct the mechanistic studies. Target study groups include: aging adults, neonates, infants and children under 5 years of age, pregnant women, and patients receiving immunosuppressive drugs for the treatment of autoimmunity or transplant maintenance.
Although progress has been made towards the original goals of this initiative, further characterization of these populations is needed, including mechanistic studies of critical immunological parameters identified during the current funding period. This solicitation will be an open competition, permitting applications from prior awardees and new applicants. Submission from incumbents will permit contractors to build on and accelerate recent progress. Proposals from new investigators open the door to examination of novel immune compromised populations and NIAID Category A, B, or C priority pathogens that were not previously supported.
The renewal initiative has been changed to include mechanistic studies of immune defects in immune compromised populations. The population categories have also been narrowed to provide a stronger focus and more possibilities for interaction between the funded contractors. Additionally, this initiative will not support projects that propose methods for enhancing the efficacy of vaccination (which was solicited in the previous initiative) because current NIAID programs already serve this need.
Immune Epitope Database and Analysis Program
Request for Proposals
Contact: Andrea Giuliano
Phone: 301-451-3685
Email: giulianoan@mail.nih.gov
Objective: This program provides a publicly available, free resource to the research community: a comprehensive database of antibody and T cell epitopes, as well as supporting data for these epitopes for infectious and immune-mediated diseases. The database is searchable and provides easy access to immune epitope information, which will enable the advancement of fundamental research on immunity to infections, the prevention and treatment of immune-mediated diseases, rational vaccine design, and the development of diagnostics and immune-based therapeutics.
Description: This initiative will support the continuation of the Immune Epitope Database and Analysis Resource (IEDB; www.immuneEpitope.org), a public Web site that houses a comprehensive database of antibody and T cell epitopes for emerging/re-emerging infectious diseases and immune-mediated diseases, with a focus on NIAID Category A-C priority pathogens. The IEDB Web site also houses a suite of antibody and T cell epitope prediction software and a suite of epitope analysis software tools. Only HIV epitopes are excluded from the IEDB, as they are covered by a separate NIAID-sponsored database devoted to HIV.
There will be no major changes in the scope of the renewal. The main goals of the program will remain the same: 1) maintain and further develop a comprehensive public database of antibody and T cell epitopes for emerging/re-emerging infectious and immune-mediated diseases, 2) develop, support, and provide epitope prediction and analysis software tools to the research community, and 3) conduct community outreach to expand community awareness and usage of this resource, as well as solicit community feedback to improve the utility of this resource for the research community. However, the scope of T cell epitope prediction tools will be decreased to eliminate development of prediction tools for specific human and murine class I alleles, since adequate tools are available publicly.
Possible funding increases (under a better budget scenario) would be used to increase the amount of epitope information contained within the database, further improve functionality of the database and Web site to enhance usability, provide additional epitope prediction/analysis tools to the research community, and increase community outreach.
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