Immunity in the Elderly (R01) Clinical Trial Optional | RFA AI 17 037

Opportunity Information: Apply for RFA AI 17 037

The Immunity in the Elderly (R01) Clinical Trial Optional funding opportunity (RFA-AI-17-037) is a National Institutes of Health (NIH) discretionary grant designed to deepen scientific understanding of how the immune system changes with age and how those changes affect real-world protection against infectious diseases and vaccine responses in older adults. A central emphasis is the practical consequence of immunosenescence and age-associated immune dysregulation: why older individuals often respond less robustly to infections and vaccinations, what biological pathways drive that decline, and what mechanisms are necessary not only to trigger protective immunity but also to maintain it over time. The announcement also explicitly connects immune aging to oral, dental, and craniofacial health, reflecting the idea that immune alterations in later life can influence local tissue health, inflammation, wound healing, and susceptibility to oral infections or chronic oral inflammatory conditions.

A defining feature of this FOA is that human studies are required. Applicants are expected to work directly with older adult populations to measure and interpret age-related immune changes in clinically meaningful contexts, such as responses to pathogens, vaccines, or immunological processes occurring in oral and craniofacial tissues. While the core evidence base must come from human research, the opportunity allows the inclusion of relevant animal studies when they are used to clarify underlying mechanisms that cannot be fully resolved in people. In other words, animal work is permitted as a supporting tool for mechanistic insight, but it cannot replace the required human component.

The FOA solicits projects in two broad, overlapping lanes. First are studies that identify the mechanisms required for the induction and maintenance of protective immunity in the elderly following infection and/or vaccination. This includes the immunological steps needed to generate effective responses (such as innate activation, antigen presentation, T and B cell priming, and development of immune memory) and the factors that determine durability (how long protection lasts and why it wanes). Within this lane, the announcement calls out chronic inflammation as a key modifier of immune responses in older adults. Applicants are encouraged to examine how persistent, low-grade inflammation associated with aging can reshape immune cell function, alter signaling pathways, change the quality of antibody and cellular responses, and ultimately influence vaccine effectiveness or susceptibility to infection. Second are studies that assess changes in immune processes in dental, oral, and craniofacial tissues in the elderly, recognizing that immune aging is not only systemic but can also present in tissue-specific ways that affect oral and craniofacial biology and disease risk.

The grant mechanism is an R01, meaning it is aimed at substantial, hypothesis-driven research projects with enough scope to address complex biological questions using rigorous study designs. The opportunity is labeled "Clinical Trial Optional," which generally indicates that applicants may propose a clinical trial if it is scientifically justified, but they are not required to do so. This allows investigators to propose a range of human-study approaches, from observational and translational studies (for example, deep immune profiling before and after vaccination, or correlates-of-protection studies tied to infection outcomes) to interventional designs where appropriate, provided the work aligns with NIH clinical research and trial policies.

Eligibility is broad and inclusive, spanning many types of domestic organizations and allowing participation by foreign organizations and regional entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-domestic (non-U.S.) entities, U.S. territories or possessions, and Indian/Native American tribal governments other than federally recognized ones. This breadth signals an intent to support a wide research ecosystem, including community-engaged institutions and organizations positioned to recruit and study diverse older adult populations.

From the administrative details provided, the opportunity falls under NIH assistance listing (CFDA) numbers 93.121, 93.855, and 93.866, reflecting NIH program areas relevant to infectious disease, immunology, and related biomedical research. The source record lists an award ceiling of $300,000, an original closing date of February 22, 2018, and a creation date of October 25, 2017. Even though those dates indicate the specific cycle referenced in the record has passed, the summary of purpose remains useful for understanding the type of projects NIH sought to fund under this reissued announcement: human-centered immunology of aging with clear relevance to infection, vaccination, chronic inflammation, and oral/craniofacial immune health.

Overall, the FOA is aimed at producing actionable, mechanistic knowledge about why immunity changes in later life and what biological levers might be targeted to improve protective responses in older adults. It encourages research that ties immune measurements to meaningful outcomes, considers the role of chronic inflammation as a driver or modifier of immune decline, and expands the lens beyond systemic immunity to include immune processes in oral and craniofacial tissues that can affect health and disease in the elderly.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Immunity in the Elderly (R01) Clinical Trial Optional" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.855, 93.866.
• This funding opportunity was created on 2017-10-25.
• Applicants must submit their applications by 2018-02-22. (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 $300,000.00 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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