Notice of Intent to Renew a Funding Opportunity Announcement for Autoimmunity Centers of Excellence (ACE) Clinical Research Program (UM1)

Notice Number: NOT-AI-17-033

Key Dates
Release Date:   August 3, 2017

Estimated Publication Date of Announcement: October/November 2017 
First Estimated Application Due Date:  June 2018 
Earliest Estimated Award Date:  April 1, 2019 
Earliest Estimated Start Date:  May 1, 2019 

Related Announcements
None

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) intend to publish Funding Opportunity Announcements (FOAs) for competitive new and renewal applications to the Autoimmunity Centers of Excellence (ACE) program, a cooperative network aimed at improving the understanding and treatment of autoimmune diseases (http://www.autoimmunitycenters.org). NIAID intends to renew both the Clinical and Basic halves of the ACE program. This Notice is being issued to allow potential applicants more time to consider the requirements of this program and to develop responsive clinical projects.
This planned FOA will solicit applications for the Clinical research program.  Members of the Clinical ACE will collaborate to design and implement clinical trials of interventions to prevent or treat autoimmune diseases. Members of the Basic and Clinical ACE will work together to design and conduct studies of mechanisms of action of potentially disease modifying agents being tested in the clinical trials.

Research Initiative Details

This The Clinical research program will develop and conduct Clinical Projects: clinical trials with integrated mechanistic studies. Well-designed clinical studies can be fundamentally informative whether or not an investigational agent ultimately advances to licensure and clinical practice.

Objectives and Scope

The ACE is designed to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases 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.  These approaches are expected to identify common and distinct mechanisms in the pathogenesis of autoimmune diseases.

The Clinical ACE will possess the following components: 

  • Center Overview: The overview describes the theme and overarching goals of the Center.        
  • Primary Clinical Project:  The Primary Clinical Project should be well along in its development so that it may be implemented within months of award. 
  • Alternate Clinical Project:  The Alternate Clinical Project must be well developed and ready to enter into full development within a year of award.
  • Collaborative Project: The Collaborative Project must be designed to exploit particular strengths of the applicant and to engage other members of the ACE after award. 
  • Administrative Core: This core coordinates the Center activities. 
  • ACE Funds Management Core: This core will administer funds on behalf of the entire group. Only a single Funds Management Core will be awarded.

The Clinical Projects will be phased for development.   

A Clinical Project is a clinical trial with integrated mechanistic studies.  A clinical trial is a medical research study in humans to evaluate the effects of one or more interventions for treatment of an autoimmune disease. Mechanistic studies are designed to improve the understanding of the mechanism of action of the intervention. In addition to assessing practical questions about the intervention, such as whether the targeted cell or molecule has been affected, these studies should be designed to address fundamental questions about human immunology.

Statistical, Data Management, and Operations Support: NIAID will provide statistical, data collection and management, and clinical trial operations support through a separately-funded DAIT Statistical and Clinical Coordinating Center (SACCC) resource. Each participating institution will be responsible for providing primary study data to the SACCC.

Research Scope: Types of Clinical Projects 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 biological mechanisms;
  • Use of unapproved drugs with well-documented, strong collaboration and endorsement from pharmaceutical partners;
  • Stratification of patients into groups that benefit or not from particular therapies, accompanied by mechanistic studies to determine why this is so.

Clinical Projects of particular interest to the ACE include but are not limited to the following areas:

  • Pathogenesis of human autoimmune disease;
  • Mechanisms responsible for the initiation, maintenance, or loss of tolerance;
  • Clinical trials of new tolerogenic and immunomodulatory approaches using individual or combined therapies including cellular therapies to treat or prevent autoimmune disease;
  • 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
  • Novel approaches to therapy applying new advances in fundamental immunity and biology, such as regulating gene transcription (methylation, acetylation), RNA metabolism (splicing, stability, miRNA, RNAi), Natural Killer (NK) inhibitor receptors (KIR), and proteins mediating signal transduction (immune synapse, intracellular pathways).  

The ACE will NOT support:

  • Primarily epidemiologic studies;
  • A clinical trial whose major goal is to enable licensing;
  • Research using animal models of human disease.

Eligibility 

A Program Director/Principal Investigator (PD/PI) may NOT apply to both the Clinical and Basic ACE program FOAs.

The Primary and Alternate Clinical Projects must have different leaders and they must address different diseases, though they may be within one clinical specialty.   

Foreign (non-US) applications and foreign components will NOT be permitted.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

David R. Johnson, PhD
National Institute of Allergies and Infectious Disease (NIAID)
Telephone: 240-627-3499
Email: drjohnson@niaid.nih.gov