NIH / Autoimmunity Centers of Excellence (U19) - Limited Submission Internal Due Date
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The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Research on Women's Health (ORWH) invite applications for the Autoimmunity Centers of Excellence (ACE) program. The major goal of the program is to support an integrated basic and clinical research program focused on tolerance induction and immune modulation to prevent or treat autoimmune disease.
This cooperative research program seeks to
- support integrated basic, pre-clinical and clinical research centers conducting cooperative clinical trials and mechanistic studies of immunologic therapies for autoimmune diseases;
- accelerate translation of basic research findings into clinical applications;
- facilitate the use of clinical samples for basic research studies;
- enhance the exchange of information among basic scientists and clinicians involved in treating autoimmune diseases; and
- establish a collaborative approach to clinical and basic research among institutions.
Basic researchers and clinicians, working together, can accelerate the translation of advances from the laboratory to the clinic and better utilize patient materials for testing mechanisms of action. NIAID, NIDDK, NIAMS, NINDS, and ORWH seek multidisciplinary centers with scientists who have new ideas, take novel approaches, and use state of the art technology to improve understanding of the basic mechanisms of autoimmunity and self tolerance and the translation of that knowledge to design and evaluate clinical interventions to prevent or treat autoimmune diseases.
The Clinical Components of the Autoimmunity Centers of Excellence will perform early clinical trials, typically phase I and phase II, and mechanistic studies, hereafter designated clinical trials/mechanistic studies, in patients with autoimmune disease(s) to test, evaluate, develop, or determine mechanism of action of agents or interventions to prevent or treat autoimmune disease by induction of tolerance or immune modulation. While industry has supported some translational activities, industry-supported trials have generally not focused on the basic mechanisms of action of these agents. Collaboration of the Autoimmunity Centers of Excellence with industry in performance of clinical trials/mechanistic studies and autoimmune disease research is encouraged.
Specific areas of interest include, but are not limited to, the following:
1. Pathogenesis of human autoimmune disease
2. Mechanisms responsible for the initiation, maintenance, or loss of tolerance
3. Clinical trials of new tolerogenic and immunomodulatory approaches using individual or combined therapies to treat autoimmune disease
4. Studies to improve understanding of existing therapies, including mechanism of action and why they may work better in subsets of patients
5. Understanding sex-based differences in autoimmune disease
6. 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
7. 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 Program will not support
- large scale epidemiology studies;
- phase 3 or phase 4 clinical trials; or
- research conducted in animal models, unless the model is highly relevant to human autoimmune disease and the project has a clear potential to translate findings to the clinic.
Each ACE application must include the components described below:
1. A clinical component, incorporating clinical specialists in several autoimmune diseases to conduct clinical trials and associated mechanistic studies that have been developed by the center and approved by the ACE Steering Committee
2. A research component, consisting of two or more individual research projects investigating the mechanisms of autoimmunity, self tolerance, or immune modulation
3. A pilot research project with discrete benchmarks of short duration and limited funding
4. One or more cores that support the work within and among the centers
