June 2017 DAIT Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Autoimmunity Centers of Excellence, Basic Component/Clinical Component

Request for Applications—proposed FY 2019 initiative

Contact: David Johnson

Objective: To renew the Autoimmunity Centers of Excellence (ACE) program, a cooperative network of integrated basic, preclinical, and clinical research centers, which is designed to:

  1. Conduct cooperative single- and multi-site clinical trials and studies of mechanisms of action of new or re-purposed candidate tolerance inducing and immune modulating interventions in autoimmune diseases.
  2. Accelerate early translation of basic research findings into clinical application.
  3. Facilitate using clinical materials for basic research studies.
  4. Enhance the exchange of information between basic scientists and clinicians and among various specialists involved in treating autoimmune diseases.
  5. Promote a collaborative approach to clinical and basic research among multiple institutions in various geographic areas.

Description: ACE includes multidisciplinary, interactive research projects focused on elucidating the basic mechanisms of autoimmunity, understanding of self-tolerance and immune modulation in autoimmune diseases, and an integrated clinical component for piloting of novel immunotherapies for autoimmune diseases. The inclusion of central cores and an integrated clinical network facilitates clinical trials and studies, basic science, and the application of basic research findings in the clinical setting. The program does not restrict the focus to particular autoimmune diseases. Programs studying more than one disease are encouraged.

Changes proposed:

  • Structural changes made in the program for the current cycle, most notably the separation into clinical (UM1) from basic (U19) research centers, as well as requiring that applications describe more developed proposals, largely succeeded in accelerating clinical trial development. Further acceleration will be sought by requiring additional documentation of feasibility and readiness, along the lines already required in applications for support of investigator-initiated clinical trials.
  • To strengthen the involvement of the clinical centers in the basic science, clinical centers will be required to propose a collaborative project.
  • To allow better planning and quicker initiation of the collaborative projects, they will receive a base funding through direct award to the Centers. They will also compete now for new and supplemental support from the Opportunity Fund.
  • Finally, applicants will be invited to propose a sample management core. A single core, scoring well in peer review, may be awarded for the entire program.

NIAID Division of Allergy, Immunology, and Transplantation: Immune-Mediated Diseases Clinical Products Center (CPC)

Request for Proposals—proposed FY 2019 initiative

Contact: Deborah Blyveis

Objective: This initiative will facilitate the ability of the Division of Allergy, Immunology, and Transplantation (DAIT) to fulfill its responsibility as a clinical trial’s sponsor to ensure that study products are received, stored, distributed, and accounted for in accordance with all federal rules and regulations and in a manner that maintains the quality of the products.

Description: This contract provides DAIT with centralized services for the receipt, storage, packaging/repackaging, manufacture of placebo, preparation of serial dilutions, labeling, distribution, inventory, and disposal of study products for clinical trials conducted by DAIT-supported clinical trials. Studies currently supported include, but are not limited to, the Immune Tolerance Network (ITN), Autoimmunity Centers of Excellence, and Clinical Trials in Organ Transportation/Clinical Trials in Organ Transportation-Children. Support for clinical product services is provided to numerous sites across the U.S. and internationally, including the Americas, Canada, the United Kingdom, Western Europe, and Australia, involving a broad range of immune-mediated diseases including: 1) asthma and allergic diseases, 2) autoimmune disorders, and 3) immune-mediated rejection in solid organ, tissue, and cell transplantation.

No change in scope of activities is anticipated. The increase in the budget base is related to supporting the work required of non-ITN studies that currently is supported through the exercise of contract options.

Investigations on Primary Immunodeficiency Diseases

Program Announcement With Special Receipt, Referral, and/or Review Considerations—proposed FY 2019 initiative

Contact: Frosso Voulgaropoulou

Objective: This initiative will support research project grant (R01) applications that propose innovative investigations in primary immunodeficiency diseases. Of particular interest are identifying primary immunodeficiency diseases; characterizing their clinical, immunological, genetic, and molecular basis; and developing innovative therapies. Ex vivo studies with human specimens, studies with current or new animal models, and in vitro state-of-the-art technologies are encouraged.

Description: This initiative will support R01 applications with primary immunodeficiency disease-specific objectives and scope, using payline funding. The applications will be reviewed by a Center for Scientific Review Special Emphasis Panel convened using experts in primary immunodeficiency diseases. No changes from the currently active funding opportunity announcement are proposed.

SBIR Radiation and Nuclear Countermeasures Program

Program Announcement—proposed FY 2019 initiative

Contact: Carmen Rios

Objective: To provide funds for preclinical product development of drugs and devices that could lead to eventual FDA licensure and inclusion of products in the Strategic National Stockpile, for potential use during a nuclear or radiological incident. Products of interest include medical countermeasures effective for the mitigation or treatment of acute radiation syndromes, radionuclide decorporation agents to treat internal contamination, and biodosimetry biomarkers/devices for determining triage and treatment strategies.

Description: This program will fund small business R43/R44 grants (Phase I, Phase II, and Phase IIB) to support developing safe and effective medical countermeasures to mitigate tissue injuries from exposure to ionizing radiation from a radiological or nuclear incident, developing drugs to remove internalized radionuclide contamination that can lead to a reduction in radiation-associated morbidities and mortalities, or biodosimetry biomarkers/devices for use in determining triage and treatment strategies for large numbers of potentially-exposed individuals. Specifically, this Program is intended to support research and development of the most promising new approaches (including but not limited to: biologics, drugs, cytokines, free radical scavengers, anti-inflammatory agents, antibiotics, cellular therapies, anti-fibrotics, and anti-apoptotics) as well as medical devices that assess, mitigate, and/or treat radiation-induced injuries.

Immunity in the Elderly

Request for Applications—proposed FY 2019 initiative

Contact: Mercy PrabhuDas

Objective: To expand understanding of the changes that occur in immune function during the aging process that contribute to impaired responses to pathogens and vaccines.

Description: This initiative will continue to support studies focused on innate and adaptive immunity, with regard to age-associated alterations in the development and function of immune responses to infections or vaccines. In addition, a deeper understanding of the intersection between immune function during aging and susceptibility to systemic inflammatory diseases is needed. Examining how aging alters communication between other cell types (e.g., platelets) and immune cells to influence host responses during aging is anticipated.

Immune Epitope Database and Analysis Program

Request for Proposals—proposed FY 2019 initiative

Contact: Emily Bannister

Objective: The Immune Epitope Database and Analysis Resource is a public repository of immune epitope data and an analysis resource that makes a variety of analytical and epitope prediction tools available to the public. The objective is to enable the scientific community to have a better understanding of the nature of immune epitopes to expedite the development of new therapies to prevent and treat infection, organ and tissue rejection, and autoimmune and allergic disorders.

Description:

  • Only public resource of its kind outside of the HIV/Los Alamos National Laboratory effort
  • Increases utility of DAIT/NIAID investments in immune epitope discovery
  • Integration with other NIAID/NIH bioinformatics resources

Changes to current program:

  • Addition of B-cell receptor/T-cell receptor repertoire data and related analysis tools
  • Greater outreach to current NIAID programs
  • Integrate FAIR (Findable, Accessible, Interoperable, and Reusable) practices for standardization
Content last reviewed on June 21, 2017