Development of Sample Sparing Assays for Monitoring Immune Responses (U24)

 
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    CFDA#

    93.855, 93.856, 93.242
     

    Funder Type

    Federal Government

    IT Classification

    B - Readily funds technology as part of an award

    Authority

    U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH)

    Summary

    This program seeks to accelerate the development and validation of sample sparing assays that can be applied for studying the human immune system in health and disease. This initiative is not aimed at the discovery of new immune signaling pathways nor the definition of new immune ligands and receptors, but rather at new ways to miniaturize or multiplex the measurement of biological markers of immune status and function. The sample sparing assays developed through this funding opportunity must address challenges, gaps or unmet needs in the study of human immune responses and provide clear advantages over existing assays. The assay development must predominately use human cells, tissues, or fluids, and validation with primary human cells, tissues or fluids is required when animal models are used. The ultimate goal of this program is to accelerate development of robust, reliable and multi-functional sample sparing assays for direct application in studies of the human immune system in healthy and diseased individuals. At the end of the award, the expectations are:
    • development of a new or significantly improved sample sparing assay,
    • assay validation studies in primary human cells or tissue, and
    • provision of Standard Operating Procedures (SOPs)/protocols and relevant data sets for the research community. 
    Sparing immune assays of interest may include, but are not limited to monitoring or assessments of the following:
    • Antigen-specific immune responses
    • Distinct immune cell populations
    • T-cell and B-cell regulatory networks
    • Innate immune responses
    • Markers of T-cell turnover and homing to lymphoid tissue
    • Cytokine and signaling networks
    • Gene and protein expression and regulation
    • Mucosal inflammatory and innate immune responses
    • Persistent HIV reservoirs in tissues of infected individuals on fully suppressive antiretroviral therapy
    • Assessing CSF samples from HIV infected adults and pediatric samples

    This program will not support:
    • Any phase clinical trial
    • Identification of new biomarkers
    • Validation of biomarker candidates
    • Studies focused exclusively on animal studies and animal disease models. Animals may be used in assay development phase but all assays must be validated using primary human samples
    • Development of assays using established cell lines without validation in primary human samples
    • Virus-induced cancers
    • Studies that do not fall within NIAID mission
     

    History of Funding

    None is available.

    Additional Information

    The NIAID’s Division of Allergy, Immunology and Transplantation (DAIT) and Division of AIDS (DAIDS) support a wide range of research programs spanning basic immunology, translational and clinical research on HIV and immune-mediated diseases, including autoimmune and primary immunodeficiency diseases, allergic diseases, graft-versus host disease (GVHD) and allograft rejection in organ, tissue and cell transplantation. DAIT and DAIDS currently sponsor a wide variety of clinical trials that incorporate a strong emphasis on defining the underlying immunological mechanisms associated with the treatment and prevention of these diseases. Major constraints encountered in designing mechanism of action studies are related to limited quantity of biological specimens available for study and the paucity of robust, validated, miniaturized assays that can reliably and reproducibly assess immune function, disease state or effects of therapy. The restricted amounts of tissue, cells and fluids that can be collected from adult, pediatric or immunocompromised patients are often inadequate for the application of conventional assays that interrogate immune function. Novel, multi-parameter, sample sparing assays are needed to obtain maximal biologic information from limited amounts of biological materials.

    Contacts

    Shellie Wilburn

    Shellie Wilburn
    U.S. Department of Health and Human Services
    National Institute of Allergy and Infectious Diseases (NIAID)
    BG 6700B RM 2117
    6700B Rockledge Dr Mail Stop: 7614
    Bethesda, MD 20817
    (301) 594-9676
    (301) 493-0597
     

  • Eligibility Details

    Eligible applicants include:

    • Higher Education Institutions
      • Public/State Controlled Institutions of Higher Education
      • Private Institutions of Higher Education
      • The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
        • Hispanic-serving Institutions
        • Historically Black Colleges and Universities (HBCUs)
        • Tribally Controlled Colleges and Universities (TCCUs)
        • Alaska Native and Native Hawaiian Serving Institutions
        • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
    • Nonprofits Other Than Institutions of Higher Education
      • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
      • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • For-Profit Organizations
    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)
    • Governments
      • State Governments
      • County Governments
      • City or Township Governments
      • Special District Governments
      • Indian/Native American Tribal Governments (Federally Recognized)
      • Indian/Native American Tribal Governments (Other than Federally Recognized)
      • Eligible Agencies of the Federal Government
      • U.S. Territory or Possession
    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    • Non-domestic (non-U.S.) Entities (Foreign Institutions)

    Deadline Details

    All non-AIDS applications are due September 26, 2014, by 5:00 p.m, local time of applicant organization. All AIDS applications are due November 18, 2014, by 5:00 p.m., local time of applicant organization. 

    Award Details

    The estimated funding available for FY15 is $5,500,000. 17 awards are anticipated. Application budgets are limited to $400,000 in total costs per year. The maximum project period is 5 years. Cost sharing/matching is not required. 

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