Human Leukocyte Antigen (HLA) and Killer-cell Immunoglobulin-like Receptor (KIR) Region Genomics in Immune-Mediated Diseases (U01 Clinical Trial Not Allowed) | RFA AI 24 017

Opportunity Information: Apply for RFA AI 24 017

This NIH funding opportunity (RFA-AI-24-017) supports cooperative agreement projects (U01; clinical trial not allowed) focused on the difficult-to-analyze HLA and KIR genomic regions and how variation in those regions shapes risk, biology, and clinical prediction in immune-mediated diseases. The core scientific aim is to move beyond broad signals and into high-resolution, well-validated genetic findings that clarify which specific HLA and/or KIR alleles, haplotypes, and structural features are associated with disease, how those associations work mechanistically in immune pathways, and how confirmed associations can be used to improve the accuracy of screening or risk prediction. In practice, applicants are expected to generate or use strong genomic and immunogenetic data to define links between HLA/KIR diversity and immune-mediated conditions, then either dig into the underlying mechanisms (for example, how particular HLA-presented peptides influence T cell responses, or how KIR-HLA interactions tune natural killer cell function) and/or perform rigorous validation to make association results more clinically reliable and generalizable.

Because this is a U01 cooperative agreement, the award structure implies substantial NIH involvement during the project period, typically including coordinated milestones, shared expectations about data quality and deliverables, and close programmatic collaboration. The NOFO explicitly excludes clinical trials, so the work should be preclinical, translational, computational, population-based, or laboratory mechanistic in nature rather than interventional studies that assign participants to treatments. The overall emphasis is on leveraging improved characterization of HLA and KIR genetics to advance therapeutic opportunities (by identifying actionable immune mechanisms or targets) and to strengthen predictive power for clinical screening (by confirming signals across cohorts, improving effect estimates, and clarifying which genetic features truly drive risk).

Eligibility is broad across U.S.-based organizations, including state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized governments; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit entities (other than small businesses); and small businesses. The NOFO also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, eligible federal agencies, and faith-based or community-based organizations, as well as U.S. territories or possessions. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components are allowed when they meet the NIH definition (for example, a discrete part of a U.S. project that is performed outside the U.S. with appropriate justification).

Administrative details provided include an original application due date of 2024-08-20, an award ceiling of $400,000, and CFDA numbers 93.853 and 93.855. The sponsoring agency is the National Institutes of Health, and the opportunity sits within the health funding activity category. Overall, the announcement is geared toward teams that can tackle the technical and analytical challenges of HLA and KIR region genomics, connect genetic variation to immune function and disease biology, and produce validated, clinically meaningful association evidence that can ultimately support better prediction and, where feasible, inform new therapeutic directions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Human Leukocyte Antigen (HLA) and Killer-cell Immunoglobulin-like Receptor (KIR) Region Genomics in Immune-Mediated Diseases (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.855.
• This funding opportunity was created on 2024-04-23.
• Applicants must submit their applications by 2024-08-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $400,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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