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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
Ancillary Studies in Immunomodulation Clinical Trials
For the published initiative, see the August 27, 2008, Guide announcement.
Request for Applications
Contact: Annette Rothermel
Phone: 301-496-5429
Email: arothermel@niaid.nih.gov
Objective: To incorporate immune mechanistic studies in clinical trials of immunomodulatory interventions for immune-mediated diseases, including, but not limited to: asthma and allergic diseases; autoimmune disorders; graft failure and graft versus host disease in transplantation; and clinical vaccine trials for infectious diseases.
Description: The renewal of this program will incorporate the same elements pioneered by the NIAID in FY 1999 to facilitate submission, peer review, and award of successful applications as early as 13 weeks after receipt for highly meritorious applications, including: 1) monthly receipt of applications; 2) monthly internet- and teleconference-based peer review; 3) negotiated assignments among participating ICs; and 4) expedited council approval. This renewal will also incorporate all aspects of RFA AI-05-028, released June 2005. Studies will focus on the inclusion of patients and utilization of patient samples for:
- Evaluation of immunologic and other relevant parameters to facilitate the study and definition of immunological mechanisms underlying the intervention;
- Definition and characterization of the mechanisms of disease pathogenesis;
- Definition of surrogate/biomarkers of disease stage, activity, and therapeutic effect;
- Definition and characterization of the human immune system; and
- Evaluation of the underlying immune mechanisms of effective responses to candidate vaccines.
Proposed mechanistic studies associated with clinical trials supported by industry are particularly encouraged; however, clinical trials supported by any source, public or private, are eligible.
Immune Defense Mechanisms at the Mucosa
For the published initiative, see the July 2, 2008, Guide announcement.
Request for Applications
Contact: Annette Rothermel
Phone: 301-496-5429
Email: arothermel@niaid.nih.gov
Objective: To support basic research projects on immune defense mechanisms and immune regulation at respiratory, gastrointestinal, and urogenital tract mucosal surfaces.
Description:
This program will solicit innovative basic research applications with the potential to increase understanding of immunity at mucosal surfaces. The goal is to gain new insights that will facilitate future development of vaccines and immunotherapies to protect mucosal surfaces from infection and inflammation. Research areas to be supported would include, but are not limited to:
- Antigen sampling across mucosal epithelial barriers.
- Role of the mucosal epithelium in innate immune signaling and antigen presentation.
- Host immune mechanisms discriminating pathogens from commensals.
- Function of specialized cells (e.g. Paneth cells, M cells) and structures (e.g. lymphoid follicles) in promoting mucosal immunity versus tolerance.
- Immunoregulation at mucosal surfaces.
Non-Human Primate Reagent Resource
Request for Proposals
Contact: Tom Bahrami
Phone: 301-451-2654
Email: bahramit@niaid.nih.gov
Objective: To renew support of the Non-Human Primate Reagent Resource. This Resource will accelerate immunological research in non-human primate (NHP) models of vaccine and adjuvant development, infectious and immune-mediated diseases, and transplantation by developing and providing reagents and technologies for (1) monitoring immune parameters, (2) in vivo modulation of the immune response, and (3) conducting immune-based mechanistic studies in NHPs.
Description: This initiative is a competitive renewal of the NIH NHP Reagent Resource, which develops, evaluates, produces, and distributes a wide variety of new or improved reagents, including novel immune-based therapeutics, for use in NHP immune-mediated and infectious disease research. The Resource develops and distributes reagents that are not commercially available or, if commercially available, are not formulated for optimum use in NHPs. The Resource provides reagents for research use only and recovers production costs for supply of significant quantities of reagents. The NIAID designates the reagents for development and distribution based on the recommendations of an NIAID-appointed Scientific Advisory Committee. The NHP Reagent Resource also maintains a Web site and online database resource for the NHP community.
Clinical Trials in Organ Transplantation (CTOT)
For the published initiative, see the June 12 , 2008, Guide announcement.
Request for Applications
Contact: Nancy Bridges
Phone: 301-451-4406
Email: NBridges@niaid.nih.gov
Objective: To support multi-center cooperative clinical trials evaluating modified or new therapeutic regimens in kidney, liver, and heart transplantation and the underlying immune mechanisms of graft acceptance or rejection. These trials will build upon new findings that become available as a result of work done in the first funding cycle in the area of noninvasive predictors of rejection and immune quiescence. Equal emphasis will be given to increasing what is known about human transplant immunology and to the application of that knowledge in the clinical setting.
Description: During the first funding cycle of CTOT, a number of clinical trials were developed and implemented to study: (1) non-invasive predictors of rejection or immune quiescence, based on gene expression profiles; (2) incidence, impact, and treatment of de novo anti-HLA antibody production after kidney transplantation; and (3) the relationship between early and late immunologic events in liver, lung, and heart transplantation. In the proposed second funding cycle, investigators will build upon these results to evaluate novel and innovative therapeutic approaches for improving the outcome of solid organ or tissue transplantation in patients with end-stage organ disease. Examples of trials to be supported include, but are not limited to: (1) proactive, individualized immune modulation strategies based upon noninvasive immunologic profiles; (2) drug minimization protocols; (3) early phase evaluation of new pharmacologic agents that target known or newly discovered immune mechanisms; (4) definitive phase III clinical trials of immunomodulatory agents for organ or tissue transplantation. Multi-center studies will be designed and implemented using rigorous standards. A data and safety monitoring board will review the clinical protocols and adjunct studies.
Statistical Centers for ACEs and Stem Cells
Request for Proposals
Contact: Wanda Neal
Phone: 301-451-3685
Email: wneal@niaid.nih.gov
Objective: To recompete the biostatistical, data management, and clinical trial operations contract that supports clinical trials of autoimmune disease.
Description: The Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) provides complete biostatistical and operational support for clinical trials in the area of autoimmune diseases. Studies currently being supported include multiple autoimmune disease clinical protocols sponsored by the Autoimmunity Centers of Excellence (ACEs), as well as autologous stem cell transplantation for autoimmune disease. Support for these and other studies in autoimmunity will include: 1) statistical leadership for the design and analysis of clinical trials, including periodic safety and administrative reports, Data Safety Monitoring Board reports, and final analyses; 2) clinical site monitoring and training; 3) data collection, management, and quality assurance programs; 4) regulatory support for IND and associated regulatory submissions, including serious adverse event data collection, evaluation and report preparation; 5) distribution and quality control of study products; and 6) support for technical and administrative functions of the clinical trial consortiums.
Reagent Development for Toll-Like and Other Innate Immune Receptors
For the published initiative, see the March 21, 2008, Guide announcement.
Request for Applications
Contact: Helen Quill
Phone: 301-435-4416
Email: hquill@niaid.nih.gov
Objective: To support multi-disciplinary projects focusing on the development of specific reagents including, but not limited to, antibodies, small molecules, and fusion proteins to study the expression and physiological function of human Toll-Like Receptors (TLRs) and other innate immune receptors. Currently, there are few reagents available to study the expression and function of these receptors. Therefore, novel reagents developed under this solicitation will help researchers to study the patterns and kinetics of the expression and functional mechanisms of these important immune receptors both in vitro and in vivo.
Description: This program will support multi-disciplinary projects focused on: (1) development of specific reagents for human TLRs and other innate immune receptors, such as NLR and RIG-1; and (2) study of the specificity and functions of these reagents. Investigators may choose to focus on the generation of natural or designer antibodies, small molecules, fusion proteins, or natural or synthetic compounds that specifically recognize and bind to human TLRs or other innate immune receptors. The goal is to develop reagents that can be used as specific tracers/markers with or without agonistic/antagonistic activities.
Rejuvenating the Aged Immune System
For the published initiative, see the March 6, 2008, Guide announcement.
Request for Applications
Contact: Alison Deckhut-Augustine
Phone: 301-594-8149
Email: adeckhut@niaid.nih.gov
Objective: To support research projects that will focus on at
least one of the following research areas:
- The mechanisms underlying age-related deficiencies in bone marrow function and development of methods to correct such defects;
- The mechanisms underlying age-related deficiencies in germinal center formation and activity, and development of methods to correct such defects; and
- The mechanisms underlying thymic involution related to aging and development of methods to reconstitute normal thymic output of T cells.
Description: This program will support basic and applied research to prevent or reverse the decline of naïve immune cell production and differentiation, including both adaptive and innate immunity, in the aged population. Research will incorporate the use of appropriate animal models and/or in vitro human cell/tissue cultures to understand the mechanisms related to decreased immune cell output and function in the elderly human population. An understanding of these mechanisms will be applied to the development of methods to reverse or prevent immune defects in the elderly. |
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