Radiation-Induced Immune Dysfunction (U01 Clinical Trial Not Allowed) | RFA AI 21 019

Opportunity Information: Apply for RFA AI 21 019

Radiation-Induced Immune Dysfunction (RFA-AI-21-019) is a National Institutes of Health funding opportunity, administered through NIAID's Radiation and Nuclear Countermeasures Program (RNCP), focused on understanding how radiation exposure disrupts immune function and how those disruptions might be prevented, reduced, or treated. The central goal is to close key scientific gaps around the mechanisms of immune injury and immune recovery after radiation, because those gaps currently limit the development of effective medical countermeasures (MCMs) for radiation incidents. The award mechanism is a U01 cooperative agreement in the health activity area (CFDA 93.855), meaning funded projects are expected to involve substantial scientific involvement from NIH program staff compared to a typical investigator-initiated grant. Clinical trials are not allowed under this announcement, so the work is expected to be preclinical, mechanistic, and translational in a non-clinical sense (for example, animal studies, biomarker work, or pathway-focused discovery and validation).

The research scope emphasizes immune-targeted radiation injuries and the broader downstream consequences of immune dysfunction. RNCP is looking for projects that can develop and refine animal models that specifically capture immune system damage caused by radiation, since robust models are essential for testing candidate MCMs and for understanding dose-response relationships and time courses of injury and repair. Beyond model development, the announcement calls for studies that map out how radiation alters immune system biology, including how immune dysregulation can contribute to multi-organ injury. In practice, this could include work on radiation effects on innate and adaptive immune compartments, immune cell depletion and reconstitution, inflammatory cascades, barrier immunity and infection susceptibility, immune-mediated tissue injury, and the interplay between hematopoietic damage and systemic immune function.

Another major emphasis is identifying immune-specific pathways that are targeted or perturbed by radiation exposure. The intent is to push the field past descriptive findings and toward actionable mechanisms: signaling pathways, cellular programs, and molecular targets that can be modulated to mitigate immune collapse, inappropriate inflammation, or immune-driven organ damage. Alongside pathway discovery, the opportunity prioritizes biomarkers of exposure and response. Biomarkers can serve multiple purposes in radiation preparedness, such as indicating exposure level, predicting who is likely to deteriorate, tracking immune injury over time, and providing pharmacodynamic readouts to show whether a candidate mitigator or treatment is engaging the intended immune-related pathway. Finally, the initiative explicitly seeks mitigators and treatments that target immune-related radiation response pathways, aligning the basic and mechanistic work with eventual countermeasure development even though human clinical trials are outside the allowable scope for this particular funding announcement.

Eligibility is broad and includes many types of domestic organizations: state, county, and local governments; special district governments; independent school districts; public housing authorities; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses, as well as other entities. The announcement also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it places clear limits on non-U.S. participation: non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means a U.S. applicant organization can include a foreign component when it is well-justified and meets NIH policy requirements, even though a foreign institution cannot be the direct applicant.

Key administrative details from the listing include the original closing date of August 24, 2021, and a creation date of April 2, 2021. While the source data does not specify an award ceiling or the expected number of awards, the overall structure and the cooperative agreement mechanism signal that NIH anticipated coordinated, programmatically aligned projects aimed at generating models, mechanistic insights, biomarkers, and candidate immune-focused interventions that can ultimately strengthen national readiness for radiation and nuclear public health emergencies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Radiation-Induced Immune Dysfunction (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): 93.855.
• This funding opportunity was created on 2021-04-02.
• Applicants must submit their applications by 2021-08-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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