Cohort Studies To Improve Our Understanding of Influenza Immunity, Vaccine Response and Effectiveness in Older Adults (65 years and older) (U01 Clinical Trial Not Allowed) | RFA AI 20 060

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The grant opportunity titled "Cohort Studies To Improve Our Understanding of Influenza Immunity, Vaccine Response and Effectiveness in Older Adults (65 years and older) (U01 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) funding announcement (Funding Opportunity Number RFA-AI-20-060) that supports research focused on how and why influenza vaccines work differently in older adults. The main purpose is to fund longitudinal cohort studies, meaning studies that follow the same group of people over time, to build a clearer, real-world picture of influenza immunity in adults aged 65 and older and to identify the immune factors that shape vaccine response and overall vaccine effectiveness in this age group.

A central emphasis of the program is improving scientific understanding of the specific elements of influenza immunity that matter most for older adults. This includes investigating which immune signatures, baseline immune states, or age-related immune changes influence whether vaccination produces a strong protective response or a weaker one. Because older adults often experience immunosenescence (age-associated immune system changes) and may have complex medical histories, the opportunity is designed to support carefully designed cohorts that can measure immune responses over time and relate those immune findings to meaningful outcomes.

Beyond measuring immune responses and vaccine effectiveness in general terms, the funding announcement also highlights severe influenza outcomes as a major focus. The goal is not only to understand who gets infected, but to better understand how immune factors and vaccine responses relate to the risk of serious disease outcomes in older adults, especially hospitalization and death. In practical terms, this kind of work can help clarify why some vaccinated older adults still experience severe influenza and which immune or clinical markers might predict vulnerability, potentially guiding improved vaccine strategies or future vaccine design.

The award mechanism is a cooperative agreement (Funding Instrument Type: U01). A cooperative agreement generally means NIH expects to have substantial involvement in the conduct of the project compared to a standard research grant, often through collaboration, coordination, or shared oversight related to program goals. The activity category is Health, and the CFDA number listed is 93.855, which corresponds to NIH infectious disease-related funding under the National Institute of Allergy and Infectious Diseases (NIAID). The announcement is explicitly labeled "Clinical Trial Not Allowed," indicating that applications should not propose prospective interventional clinical trials as defined by NIH. Instead, the work should be observational or otherwise structured to fit within non-trial research, such as cohort follow-up, immune profiling, and analysis of vaccine responses and outcomes in real-world settings.

Eligibility for this opportunity is broad and includes many types of U.S. organizations and governments, such as state, county, city, and 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; and tribal organizations that are not federally recognized. It also allows participation from public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories), for-profit organizations (other than small businesses), and small businesses. The announcement also explicitly encourages or includes a wide range of additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects an interest in building cohorts that can represent diverse older adult populations and potentially leverage existing community and healthcare networks.

Key administrative details in the source data include an original closing date of February 4, 2021, and a creation date of September 30, 2020. The award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants would need to consult the full announcement text for budget guidance, scope expectations, and programmatic priorities. Overall, the opportunity is designed to strengthen the evidence base around influenza immunity and vaccination in adults 65 and older by supporting long-term cohort-based research that connects immune measurements to vaccine performance and, critically, to severe influenza outcomes.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Cohort Studies To Improve Our Understanding of Influenza Immunity, Vaccine Response and Effectiveness in Older Adults (65 years and older) (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 2020-09-30.
• Applicants must submit their applications by 2021-02-04. (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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