RFA-AI-18-002: Autoimmunity Centers of Excellence, Basic Research Program (U19 Clinical Trial Not Allowed)
Internal Deadline: Contact the Office of Research if interested.
LOI: May 22, 2018
External Deadline: June 22, 2018
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: NIAID anticipates 3-5 awards within the ACE Basic Research Program.
Anticipated Amount: NIAID plans to commit $8.48 million overall to the ACE in fiscal year 2019, which includes direct costs of up to $3.2M annually to support an ACE Clinical Project Fund and an ACE Collaborative Project Fund
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- 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.
- CV – (5 pages maximum)
Who May Serve as PI: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
This FOA solicits applications for the Basic research program of the Autoimmunity Centers of Excellence (ACE). The companion FOA, RFA-AI-18-003, solicits applications to the Clinical research program of the ACE. The goal of the ACE is to conduct insightful analyses of human immunology as it applies to autoimmune disease(s) within and among collaborative Centers and especially in the context of Clinical Projects, i.e., clinical trials with integrated mechanistic studies. The members of the Basic and Clinical ACE will work together after award to design, develop, and conduct studies of autoimmunity and autoimmune diseases in humans. This approach is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating agents used in therapy or tested in clinical trials.
The objectives of the ACE are to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE program approaches these objectives by conducting cooperative basic, clinical, and mechanistic studies, fostering intellectual and material collaborations among basic and clinical scientists, and facilitating the study of clinical samples by basic research scientists. Projects designed to test explicit hypotheses are preferred though ‘data-driven’ projects are permitted. The program is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating agents used in therapy or tested in clinical trials.
Research Scope: All projects must investigate autoimmune disease in humans.
Principal, Pilot, and Collaborative Projects: These Projects may use samples from previously completed clinical trials or studies but they may not support a clinical trial. For these Projects, specific areas of interest include, but are not limited to:
- Pathogenesis of human autoimmune disease;
- Mechanisms of action of existing therapies for autoimmune disease;
- Biomarkers for autoimmune disease status, including diagnosis, disease progression, prediction of remission or relapse, therapeutic response, and stratification;
- Sex-based differences in autoimmune disease;
- Mechanisms responsible for the initiation, maintenance, or loss of tolerance;
- Cellular diagnosis or cell therapy, including adult stem cells, regulatory B and T cells, and antigen-presenting cells;
- Single-cell or clonal analysis of genetic variation (including epigenetic) contributing to autoimmunity;
- Influence of histocompatibility genes (e.g., HLA) on autoimmunity; and
- Novel mechanistic approaches to therapy applying advances in fundamental immunity and biology, such as gene therapy, regulating gene transcription (epigenetics, methylation, acetylation), RNA metabolism (splicing, stability, miRNA, RNAi), antigen receptors or Natural Killer (NK) inhibitor receptors (KIR), lymphocyte subsets, dendritic cells, cytokines, chemokines, proteins mediating signal transduction (immune synapse, intracellular pathways), metabolomics and the microbiome.
Applications proposing the following will be considered non-responsive and will not be reviewed:
- Large scale epidemiology;
- Research using animal models of human disease (“humanized” animals are not permitted);
- Clinical trials;
- Projects focused on primary immune deficiency or cancer (though studies of autoimmunity including these patient populations are responsive);
- Projects focused on HIV/AIDS;
Projects that do not investigate autoimmune disease in humans.