June 2018 Trans-Divisional Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

NB: Council approval does not guarantee that a concept will become an initiative.

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Expanding Extramural Research Opportunities at the NIH Clinical Center

Program Announcement With Special Receipt, Referral, and/or Review Considerations—proposed FY 2019 initiative

Contact: Dean Follmann

Objective: The goal of this funding opportunity announcement (FOA) is to support extramural investigator-initiated clinical research in collaboration and partnership with the NIH Clinical Center in Bethesda, Maryland. This new FOA will leverage the resources (inpatient and outpatient) and assets of the NIH Clinical Center (e.g., scientific and clinical trial expertise, nursing, beds, critical care services, ambulatory care services, laboratories, imaging, biostatistics, protocol development, regulatory guidance, clinical trials management and safety oversight) in accelerating the discovery and translation from laboratory to clinic of therapies for infectious, immunologic, and allergic diseases.

The NIAID mission is to conduct and fund research to understand, treat, and prevent infectious, immunologic, and allergic diseases. The NIAID Strategic Plan 2017 describes scientific priorities. Extramural scientists proposing research within NIAID’s priorities have the opportunity to use the unique resources of the Clinical Center (for a description of resources, see Research Resources at the NIH Bethesda Campus).

Description: This FOA will specifically support hypothesis-driven mechanistic studies alone or within clinical projects employing small Phase 0, 1, and/or 2a clinical trial designs. In the context of the FOA, a clinical project is a clinical trial together with integrated mechanistic studies.

Types of clinical trials and clinical research that may be proposed include but are not limited to the following:

  • Phase 0 clinical trials in healthy subjects [e.g., assess safety and explore pharmacokinetic (PK) characteristics of promising interventional agents (e.g., drugs, cells, and molecules) or new formulations of FDA-approved drugs (e.g., calcineurin inhibitor immunosuppression)]
  • Observational clinical research with associated mechanistic studies and/or genetic studies
  • Chronic allograft injury and destruction after organ transplantation
  • Treatment of post-transplant cancers
  • Treatment of post-transplant lymphoproliferative disease (PTLD)
  • Identification of genetic determinants of outcome or response to therapy in organ transplant recipients
  • Infectious disease challenge studies in healthy volunteers
  • Phase 1 (initial safety trial) and 2a pilot clinical trials to evaluate efficacy and safety in patients with the immune-mediated disease or condition to be treated, diagnosed, or prevented
  • Repurposing drugs approved for other indications for diseases within the NIAID mission based on the known mechanism of the drug
  • Cross-sectional and epidemiologic studies in specific disease cohorts looking at intermediate and long-term follow-up
  • Evaluation of immune response to licensed vaccines in special populations
  • Infectious diseases studies in special populations, including primary immunodeficiency diseases, concurrent diseases states, cystic fibrosis
  • New therapeutic approaches applying cutting-edge advances in fundamental immunity and biology. Examples include: microbiome, gene therapy, regulating gene transcription, RNA metabolism, cellular therapy, cytokines, chemokines, and proteins mediating signal transduction
  • Development of diagnostic, predictive, and critical biomarkers that will facilitate routine surveillance, early diagnosis, and ongoing monitoring of processes that contribute to morbidity and mortality for immune-mediated diseases (e.g., organ transplantation, autoimmune disease, allergy and asthma)

Specific areas of interest include:

  • Clinical research focused on the high-priority areas in HIV/AIDS within the NIAID mission (NOT-OD-15-137, NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding)
  • Allergy
  • Food allergy
  • Eosinophilic and/or mast cell disorders
  • Anaphylaxis
  • Drug allergy including interest in immunologic basis of severe adverse drug reactions, diagnosis of drug allergy, role of IgE in drug allergy
  • Atopic dermatitis (eczema) and other allergies (e.g., rhinitis, rhinosinusitis)
  • Primary immunodeficiency diseases
  • Rare diseases in the areas of infectious, primary immunodeficiency, autoimmune, and allergic diseases
  • Acute and chronic inflammatory disease (e.g., inflammatory bowel disease)
  • Human immunology in context of biodefense
  • Transplantation immunology (organs, tissues, cells, and molecules)
  • New interventional immunotherapeutics
  • Host defense
  • Infectious diseases
  • Novel therapeutic vaccination approaches

It is anticipated that the extramural research itself will be largely conducted at the Clinical Center, with some additional NIAID support for work to be performed in the extramural investigator’s laboratory. While collaboration with intramural investigators is allowed, it is not required. Moreover, projects that take only minimal advantage of Clinical Center resources, such as projects using only banked samples or data, will not be considered for NIAID support.

Content last reviewed on June 19, 2018