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You are here: Home / Limited Submissions / RFA-AI-22-012: Immune Drivers of Autoimmune Disease (IDAD) (U01 Clinical Trial Not Allowed)

RFA-AI-22-012: Immune Drivers of Autoimmune Disease (IDAD) (U01 Clinical Trial Not Allowed)

Slots: 1

Deadlines

Internal Deadline: Contact ORIF.

LOI: June 1, 2022

External Deadline: July 1, 2022

Award Information

Award Type: Cooperative Agreement

Estimated Number of Awards: 3 – 4

Anticipated Award Amount: $3.6 million overall

Who May Serve as PI: Standard NIH language.

Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-22-012.html

Process for Limited Submissions

PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.

Materials to submit include:

  • (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
  • (2) CV – (5 pages maximum)

Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.

Purpose

This Funding Opportunity Announcement (FOA) invites applications to participate in 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.

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 must 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

Although these studies should be designed to be self-standing, collaboration among members of the research group will be encouraged. Areas of interest include, but are not limited to:

  • Mechanisms by which genetic variants influence the course, progression, or clinical features of one or more autoimmune diseases;
  • Biomarkers for flare, remission, or progression of autoimmune disease;
  • Evolution and regulation of immune responses during disease progression or flare;
  • Refinement of molecular-level markers of autoimmune diseases into mechanistic understanding of cellular and/or humoral immune dysfunction in those diseases;
  • Elucidation of immunologically distinct endotypes within autoimmune diseases;
  • Mechanisms by which environmental or microbial influences modulate immune responses to result in flare, remission, or progression of disease;
  • Improving the ability to define relative risks for development of autoimmune disease among clinically healthy individuals or among individuals already diagnosed with one autoimmune disease;
  • Analyses of pre-existing specimens to determine the nature of molecular profiles or other biomarkers that are likely to be both obtainable and informative in terms of predicting the ultimate course of human autoimmunity.

Applicants are highly 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.

Visit our Institutionally Limited Submission webpage for more updates and other announcements.


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