Opportunity Information: Apply for RFA AI 27 019
Apply for RFA AI 27 019
- 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 2026-02-10.
- Applicants must submit their applications by 2026-06-04. (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 $3,000,000.00 in funding.
- The number of recipients for this funding is limited to 3 candidate(s).
- 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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Opportunity Summary:
This funding opportunity, titled "Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)" (RFA-AI-27-019), is a National Institutes of Health (NIH) cooperative agreement designed to build or continue long-term (longitudinal) infant cohorts that can be followed over time to understand how early-life influenza exposures shape immune development. The central focus is on the very first influenza encounters in infancy and early childhood, and how those initial events, followed by later infections and/or vaccinations, influence the quality, durability, and breadth of immune responses to future influenza viruses or influenza vaccines. The practical reason NIH is supporting this work is to generate the kind of real-world, time-based immunology evidence needed to design influenza vaccines that protect more broadly and last longer, especially across the many strains and changes that influenza undergoes over time.
The research supported under this NOFO is expected to compare different exposure pathways, including natural influenza infection, influenza vaccination, and combinations or sequences of both. By tracking infants and children across multiple seasons and exposures, the cohorts should be able to answer questions such as how the immune system is "imprinted" by the first influenza strain encountered, whether vaccination as a first exposure produces different immune memory than infection, how repeated exposures reshape antibody and cellular responses, and which immune signatures are linked with better protection against later influenza. Although the announcement does not list specific study designs in the text provided, the emphasis on longitudinal cohorts implies repeated sampling and follow-up over time, with careful documentation of infections, vaccinations, and subsequent immune measurements in order to connect exposure history with immune outcomes.
The award mechanism is a U01 cooperative agreement, which typically means NIH scientific staff will have substantial involvement during the project, beyond what is typical for standard grants. This can include coordinated planning, shared milestones, and active programmatic collaboration to ensure the cohorts and data are structured in ways that maximize comparability and usefulness for the broader influenza research community. The NOFO explicitly states "Clinical Trial Not Allowed," meaning applicants must keep the work within observational and non-trial boundaries as defined by NIH, rather than proposing an interventional clinical trial where participants are prospectively assigned to interventions to evaluate health outcomes. In practice, this points investigators toward cohort establishment, surveillance, immunologic profiling, and analysis of exposures occurring through standard of care or natural circulation, rather than experimental assignment to vaccination strategies.
In terms of funding scale and competition, NIH expects to make about three awards under this opportunity, with an award ceiling of up to $3,000,000. The original closing date is June 4, 2026, and the program is categorized under health (CFDA 93.855). Because the anticipated number of awards is small and the budget cap is high, the solicitation appears aimed at substantial, well-organized cohort efforts capable of long follow-up, consistent specimen collection, and high-quality immunologic assays, data management, and analytic capacity.
Eligibility is broad and includes many common applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations. The NOFO also permits non-U.S. entities to apply directly, allows non-U.S. components of U.S. organizations, and allows foreign components as defined in the NIH Grants Policy Statement, which can matter for cohorts located outside the United States or studies that rely on specialized sites, populations, or laboratory capabilities abroad.
At the same time, the international collaboration rules are strict in a way that will affect how applicants structure partnerships and budgets. NIH states it will no longer issue awards to domestic or foreign entities that involve foreign subawards or subcontracts, with the requirement taking effect May 1, 2025. Under this specific NOFO, any application that includes foreign subawards/subcontracts will be considered noncompliant and will not be reviewed for funding. This is an important distinction: the policy does not prohibit all international involvement, but it does prohibit monetary arrangements that would constitute a foreign subaward/subcontract under the grant. The NOFO clarifies that unfunded international collaborations may still occur, foreign components may be allowed, foreign consultants may be paid, and unique equipment or supplies may be procured from foreign vendors. The key compliance issue is avoiding a structure where grant funds flow to a foreign institution as a subrecipient/subcontractor under the award, unless the NOFO is specifically designated for funded international collaborations (which this one is not, based on the text provided).
Overall, the opportunity is aimed at generating definitive, longitudinal evidence about how infants immune systems are shaped by their earliest influenza experiences, and how those early exposures influence later immunity, protection, and vaccine responsiveness. By supporting a small number of relatively large cohort projects under a cooperative agreement model, NIH is signaling that standardized, high-quality cohort infrastructure and immune profiling over time are priorities, with the end goal of informing next-generation influenza vaccine designs that provide broader and more durable protection across childhood and beyond.
FAQs: Impact of Initial Influenza Exposure on Immunity in Infants (RFA-AI-27-019)
What is this funding opportunity?
This opportunity is an NIH cooperative agreement (U01) titled "Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)" (RFA-AI-27-019). It supports building or continuing long-term (longitudinal) infant cohorts to study how early influenza exposures shape immune development over time.
What is the main goal of the research NIH wants to support?
The main goal is to understand how the very first influenza encounters in infancy and early childhood affect the quality, durability, and breadth of immune responses to future influenza viruses and/or influenza vaccines. NIH is supporting this work to generate time-based, real-world immunology evidence that can guide the design of broader and longer-lasting influenza vaccines.
What does "initial influenza exposure" mean in this context?
It refers to an infant's first meaningful encounter with influenza, such as the first natural influenza infection, the first influenza vaccination, or a combination/sequence of infection and vaccination early in life.
Why is the first exposure considered so important?
The NOFO highlights that early exposures may "imprint" the immune system. The cohorts are expected to help determine how the first strain encountered shapes later immune memory and how that early imprint influences responses to later infections and vaccinations.
What kinds of exposure pathways are expected to be compared?
The supported research is expected to compare different pathways, including natural influenza infection, influenza vaccination, and combinations or sequences of both (for example, vaccination first then infection later, or infection first then vaccination later).
What outcomes or questions are these cohorts expected to address?
Based on the description provided, cohorts should be able to address questions such as: whether vaccination as a first exposure produces different immune memory than infection; how repeated exposures reshape antibody and cellular responses; and which immune signatures are linked with better protection against later influenza.
Does the NOFO require a particular study design?
The provided text does not list specific study designs. However, the emphasis on longitudinal infant cohorts implies repeated follow-up and sampling over time, along with careful documentation of infections, vaccinations, and immune measurements to connect exposure history with immune outcomes.
What does "longitudinal cohort" imply for this opportunity?
It implies enrolling infants and following them over time (potentially across multiple seasons), tracking influenza infections and vaccinations, and collecting immune data repeatedly so investigators can analyze how immunity evolves after each exposure.
What is the award mechanism and what does U01 mean for applicants?
The mechanism is a U01 cooperative agreement. This typically means NIH scientific staff will have substantial involvement during the project, beyond what is typical for standard grants. The opportunity description notes this can include coordinated planning, shared milestones, and active programmatic collaboration to help ensure cohorts and data are structured for comparability and broader usefulness.
Are clinical trials allowed under this opportunity?
No. The NOFO explicitly states "Clinical Trial Not Allowed." Applicants must keep the work within observational and non-trial boundaries as defined by NIH, rather than proposing an interventional clinical trial where participants are prospectively assigned to interventions to evaluate outcomes.
What types of activities does "Clinical Trial Not Allowed" point investigators toward?
Based on the description, it points toward cohort establishment, surveillance, immunologic profiling, and analyses of exposures that occur through standard of care or natural influenza circulation, rather than experimental assignment to vaccination strategies.
How many awards does NIH expect to make?
NIH expects to make about three awards under this opportunity.
What is the maximum budget mentioned for an award?
The award ceiling is up to $3,000,000.
When is the closing date for the opportunity?
The original closing date is June 4, 2026.
What is the CFDA number and program area?
The program is categorized under health with CFDA 93.855.
Who is eligible to apply?
Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments and tribal organizations.
Can non-U.S. organizations apply?
Yes. The NOFO permits non-U.S. entities to apply directly. It also allows non-U.S. components of U.S. organizations and foreign components (as defined in the NIH Grants Policy Statement).
Does this NOFO allow international cohorts or work outside the United States?
The description indicates that foreign components may be allowed and that non-U.S. entities may apply directly, which can support cohorts located outside the U.S. or studies relying on specialized sites, populations, or laboratory capabilities abroad.
What is the policy on foreign subawards or foreign subcontracts?
NIH states it will no longer issue awards to domestic or foreign entities that involve foreign subawards or subcontracts, with the requirement taking effect May 1, 2025. Under this NOFO, any application that includes foreign subawards/subcontracts will be considered noncompliant and will not be reviewed for funding.
Does the foreign subaward/subcontract restriction prohibit all international involvement?
No. The description clarifies that the policy does not prohibit all international involvement. Unfunded international collaborations may still occur, foreign components may be allowed, foreign consultants may be paid, and unique equipment or supplies may be procured from foreign vendors.
What is the key compliance risk related to international partnerships?
The key compliance issue is avoiding a structure where grant funds flow to a foreign institution as a subrecipient/subcontractor under the award. If an application includes a foreign subaward/subcontract, it will be noncompliant and not reviewed under this NOFO.
What is the practical reason NIH is supporting this work?
The practical reason stated is to generate the real-world, time-based immunology evidence needed to design influenza vaccines that protect more broadly and last longer, despite influenza strain diversity and ongoing viral changes.
What kind of projects does NIH appear to be targeting with this solicitation?
Because the number of anticipated awards is small and the budget cap is high, the solicitation appears aimed at substantial, well-organized cohort efforts capable of long follow-up, consistent specimen collection, high-quality immunologic assays, data management, and strong analytic capacity.
What is the ultimate long-term outcome NIH is aiming for?
The long-term aim described is to inform next-generation influenza vaccine designs that provide broader and more durable protection across childhood and beyond.
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