Notice of Intent to Publish a Funding Opportunity Announcement for Immune Drivers of Autoimmune Disease (U01 Clinical Trial Not Allowed)
Notice Number:
NOT-AI-22-017

Key Dates

Release Date:
December 09, 2021
Estimated Publication Date of Funding Opportunity Announcement:
February 14, 2022
First Estimated Application Due Date:
July 01, 2022
Earliest Estimated Award Date:
March 01, 2023
Earliest Estimated Start Date:
March 01, 2023
Related Announcements

None

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications to establish the Immune Drivers of Autoimmune Disease (IDAD) cooperative research program, which will focus on defining the immunologic states and dynamics that drive autoimmune disease. The main objective of this program is to improve our understanding of the immunologic processes and events that drive not only the course of autoimmune disease but also the preclinical phase and the transition from subclinical autoimmunity to diagnosed autoimmune disease. A secondary objective is to establish innovative approaches that will facilitate further studies by enhancing feasibility of large-scale studies and reducing both financial costs and the burden to subjects.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

Research Initiative Details

The objective of the IDAD program is to improve our mechanistic understanding of the immunologic processes underlying the initiation, progression, and clinical course of autoimmune diseases in humans. Research projects proposed in response to this FOA should test hypotheses related to this objective and will be required to adhere to the following parameters:

  • All studies must be performed using human subjects and/or materials
  • Some portion of the project must involve subjects at elevated risk of developing one or more autoimmune diseases (i.e., at greater risk than healthy subjects from the general population)
  • Studies may also involve subjects already diagnosed with autoimmune disease
  • Studies may focus on the development of additional autoimmune disease(s) in subjects previously diagnosed with an autoimmune disease

Applicants will also be encouraged to incorporate and test novel approaches or combinations of approaches that hold promise to reduce the cost and clinical burden of longitudinal cohort studies. These approaches include, but are not limited to:

  • Determining the relative advantages of using peripheral blood and other biospecimens for obtaining immunologically valuable data;
  • Devices, approaches, and techniques for long-term, low-cost, non-invasive or minimally invasive monitoring of subjects for the onset of autoimmune disease;
  • Devices, approaches, and techniques for procuring frequent biospecimens from subjects in a manner that minimizes burden to subjects and financial costs (e.g., at-home self-sampling);
  • Analytic approaches that will enable extraction from small biospecimens of immunologic data pertinent to understanding the immunologic events that drive clinically relevant changes in autoimmune disease;
  • Comparisons of bulk or single-cell RNA sequencing, measurement of soluble mediators, cellular phenotypic analysis, or a combination of approaches as the optimal readout for a prospective observational study of the preclinical phase of human autoimmune disease.

Eligibility

Only one application per institution will be allowed. Foreign (non-US) applications and foreign components will be allowed.

Funding Information
Estimated Total Funding

$3,600,000

Expected Number of Awards

NIAID anticipates funding up to 4 awards, contingent upon the availability of funds

Estimated Award Ceiling

NIAID intends to cap direct costs at $750,000 annually for each award

Primary Assistance Listing Number(s)

93.855

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Thomas Esch, Ph.D.

National Institute of Allergy and Infectious Diseases (NIAID)

240-627-3565


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices