RFA-AI-18-003: Autoimmunity Centers of Excellence, Clinical Research Program (UM1 Clinical Trial Required)
Internal Deadline: Contact the Office of Research if interested.
LOI: May 22, 2018
External Deadline: June 22, 2018, by 5:00 PM
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: Overall support will be divided between the Clinical and Basic programs: NIAID anticipates 2-4 awards within the ACE Clinical 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.
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.
Clinical Projects developed by the ACE should be innovative and propose clear, testable hypotheses on underlying immune mechanisms. Mechanisms of interest include the intervention, the disease, and fundamental immunity. The proposed Clinical Projects may aim to generate initial evidence of efficacy and mechanism, using resources appropriate to the scope of the ACE network. A Clinical Project may not be shared between applications to this FOA. Only unique Clinical Projects will be selected for funding. Applicants may propose collaborations with other investigators (who may also be applicants), but the complete Clinical Project must be contained within a single application
Types of trials that may be proposed include but are not limited to the following:
- Combinations of approved drugs;
- Comparative effectiveness research using approved drugs;
- Repurposing drugs approved for other indications, based on the understood mechanism of the drug;
- Use of unapproved drugs with evidence of strong collaboration and endorsement from pharmaceutical partners though it is not the purpose of the ACE to support critical path development for industry;
- New tolerogenic and immunomodulatory approaches using individual or combined therapies including cellular therapies to treat or prevent autoimmune disease; and
- Novel 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), and the microbiome.
Clinical Projects of particular interest to the ACE include, but are not limited to the following:
- Pathogenesis of human autoimmune disease;
- Mechanisms responsible for the initiation, maintenance, or loss of immune tolerance;
- Understanding existing therapies, including mechanism of action and why they may work better in subsets of patients;
- Understanding sex-based differences in autoimmune disease;
- Identification and evaluation of biomarkers for autoimmune disease status, including diagnosis, prediction or confirmation of remission or relapse, and measurement of therapeutic response or disease progression; and
- Stratification of patients into groups that benefit or not from particular therapies, accompanied by mechanistic studies to determine why this is so.
Applications proposing the following for Clinical Projects will be considered non-responsive and will not be reviewed:
- Mechanistic studies within industry-supported clinical trials;
- Non-interventional clinical studies;
- A clinical trial whose primary goal is to enable licensing;
- Research using animal models of human disease (“humanized” animals are not permitted);
- Projects without integrated mechanistic studies;
- Projects focused on primary immune deficiency or cancer (though studies of autoimmunity including these patient populations are responsive);
- Projects focused on HIV/AIDS;
- On-going clinical trials;
- Projects that do not investigate autoimmune disease in humans.
A Clinical ACE application must include two Clinical Projects (Primary and Alternate), a Collaborative Project, an Administrative Core, and an ACE Funds Management Core. These elements are described below:
Administrative Core: The administrative core is responsible for providing overall leadership to the Center, including management, coordination, and oversight for the Center activities.
ACE Funds Management Core (AFMC): This core will administer, on behalf of the entire ACE, two funds: the Clinical Project Fund for support of the Clinical Projects and the Collaborative Research Fund for support of the Collaborative Projects and additional studies required for achieving the aims of the ACE Research Agenda. One of the applicants will be selected by NIAID after award to administer the AFMC. Clinical and Collaborative Projects will be funded through the recipient of the ACE Funds Management Core.
Visit our Institutionally Limited Submission webpage for updates and other announcements.