Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed) | RFA AI 18 010

Opportunity Information: Apply for RFA AI 18 010

The National Institutes of Health (NIH) released this discretionary funding opportunity, RFA AI 18 010, titled "Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)." It uses the U01 cooperative agreement mechanism, which means projects are supported as a partnership between the funded investigators and NIH program staff, with substantial scientific or programmatic involvement from the agency compared with a typical research project grant. The scientific area falls under health research (CFDA 93.855), and the central goal is to generate knowledge that can guide the development of longer-lasting and more broadly protective influenza vaccines by studying how immunity develops early in life.

The focus of the announcement is on "immunological imprinting" in infancy: how a babys first influenza exposures shape immune responses later on. Specifically, the FOA aims to determine how immunity created by an infants initial influenza infection, and then shaped further by later infections and/or vaccinations, influences protection against future influenza exposures. The research emphasis is on longitudinal human infant cohorts, meaning investigators are expected to follow infants over time, repeatedly measuring immune responses and documenting influenza infections and vaccination history as they occur. By tracking the sequence and timing of exposures and the immune responses that follow, the studies supported under this FOA are meant to clarify which early immune patterns are associated with stronger, more durable protection and which patterns may leave gaps in protection later in childhood.

Because the FOA is labeled "Clinical Trial Not Allowed," the intent is not to run an interventional clinical trial where participants are prospectively assigned to specific interventions for the purpose of evaluating health outcomes. Instead, projects would generally be expected to be observational or otherwise non-trial human research, such as following natural infection events, documenting routine vaccination, and performing immunologic profiling over time. The end product NIH is looking for is a clearer picture of how early-life exposure history influences the development of protective immunity, with the explicit translational aim of informing durable, broadly protective influenza vaccine design.

Eligibility is broad and includes many types of U.S. organizations and governments: state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (outside higher education); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The announcement also highlights additional eligible applicant categories, including 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, U.S. territories or possessions, regional organizations, tribal governments other than federally recognized, and non-U.S. entities (foreign organizations). This wide eligibility suggests NIH was encouraging participation from diverse institutional settings and communities, which is especially relevant for infant cohort work that often benefits from strong community ties and access to varied populations.

Key administrative details included an original application closing date of July 2, 2018, and a stated award ceiling of $3,100,000. The FOA record lists "ExpectedAwards" without a specific number in the provided excerpt, so the exact count is not stated here. The opportunity was created on April 5, 2018. Overall, the grant opportunity is best understood as NIH support for carefully designed, long-term infant cohort studies that can connect early influenza exposure patterns (infection and/or vaccination) to measurable immune trajectories and later protection, producing evidence that can be used to design influenza vaccines that work well across strains and remain protective for longer periods.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Impact of Initial Influenza Exposure on Immunity in Infants (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 2018-04-05.
• Applicants must submit their applications by 2018-07-02. (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 $3,100,000.00 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.

Apply for RFA AI 18 010

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: