Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers studying how initial influenza exposure shapes infant immune responses. NIH U01 research grants support collaborative research projects that require coordinated, multi-disciplinary efforts. Applicants must be institutional representatives (universities, medical schools, research hospitals, nonprofits with research capacity). Principal investigators need a doctorate or equivalent research degree. Projects must focus on research activities only—clinical trials are explicitly not allowed. Domestic and international institutions can apply if they have U.S. federal funding eligibility.
This grant is for researchers studying how initial influenza exposure shapes infant immune responses. NIH U01 research grants support collaborative research projects that require coordinated, multi-disciplinary efforts. Applicants must be institutional representatives (universities, medical schools, research hospitals, nonprofits with research capacity). Principal investigators need a doctorate or equivalent research degree. Projects must focus on research activities only—clinical trials are explicitly not allowed. Domestic and international institutions can apply if they have U.S. federal funding eligibility.
Program description
The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. The goal of this research is to understand how these exposures influence immune responses to subsequent influenza infections and/or vaccines and provide key information to facilitate design of durable, broadly protective influenza vaccines.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for researchers studying how initial influenza exposure shapes infant immune responses. NIH U01 research grants support collaborative research projects that require coordinated, multi-disciplinary efforts. Applicants must be institutional representatives (universities, medical schools, research hospitals, nonprofits with research capacity). Principal investigators need a doctorate or equivalent research degree. Projects must focus on research activities only—clinical trials are explicitly not allowed. Domestic and international institutions can apply if they have U.S. federal funding eligibility.
How to apply
Application links
Required documents
- SF-424 (R&R) form
- SF-424 (R&R) cover page
- Project Narrative (research plan)
- Specific Aims (1 page max)
- Significance and Innovation sections
- Approach and Methods
- Preliminary Data/Results
- Literature Cited
- Budget and Budget Justification
- Biographical Sketches (all key personnel)
- Resources and Environment description
- Letters of Institutional Support (if multi-site)
Program contact
- 👤 National Institutes of Health
- 📧 imprintingNOFO@mail.nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.855 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$438,527,853
-
$246,626,852
-
$204,359,786
-
$201,437,825
-
$200,221,259
-
$185,816,804
-
$180,737,624
-
$136,265,880
-
$116,817,868
-
$99,478,296
Top States by Funding
- CA 10 awards $812.7M
- WA 3 awards $684.0M
- MA 6 awards $602.8M
- NC 3 awards $446.4M
- NY 7 awards $375.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.855). How funding has trended year over year.
| 2024 | $4,073,812,529 | |
| 2025 | $4,378,235,639 | |
| 2026 est. | $4,299,426,996 |
FAQ
Can I submit a clinical trial under this U01?
No. This mechanism explicitly excludes clinical trial applications. Basic research and observational studies are appropriate.
Who can be the Principal Investigator?
PIs must hold a doctorate or equivalent terminal research degree. Faculty, senior scientists, and established researchers typically qualify.
What institutions are eligible?
Universities, medical schools, hospitals, and nonprofits with research infrastructure can apply. Your institution must be capable of executing federally-funded research.
How competitive is this funding?
U01s are highly competitive. NIH funds roughly 15-25% of applications. Strong preliminary data and experienced research teams improve odds significantly.
What is the typical funding range?
U01s typically award $200,000–$500,000+ annually depending on scope. Multi-site projects tend to receive larger awards.
💡 Tips for applicants
- Demonstrate strong preliminary data showing why your team is ready for collaborative research on infant immunity and influenza.
- Build a realistic multi-site or multi-disciplinary team if your study design requires coordination across institutions or expertise areas.
- Use the application open date (February 2026) to allow 4+ months for planning, team alignment, and data refinement before submission.
- Follow NIH formatting rules precisely: strict page limits, specific font sizes, and required sections vary by grant type—review the FOA before writing.
- Address the scientific review committee's likely focus on feasibility, innovation, and the strength of your preliminary findings about early immune responses.
⚠️ Common mistakes
Submitting a clinical trial design when the FOA explicitly excludes them. Many applicants miss this detail and waste effort.
Assembling a team without clear leadership and coordination roles. U01s demand structured collaboration—vague shared responsibility fails review.
Underestimating preliminary data expectations. NIH reviewers expect solid foundational evidence, not just hypotheses.
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