Early Immune System Development and Ontogeny (R01 Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for biomedical researchers studying early immune system development and its mechanisms. Eligible applicants include researchers at universities, medical schools, research institutions, and nonprofits. Domestic and international organizations with U.S. research capability can apply. Applications may be for basic research, clinical research, or mixed approaches exploring immune system ontogeny.
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Program description
The purpose of this Notice of Funding Opportunity (NOFO) is tofurther elucidate the mechanisms of early immune development in utero, during the early post-natal period and during early childhood in neonates, infants, and children and adolescents with or without in-utero exposure to HIV or Anti-Retroviral Therapeutics (ART).This initiative aims to understand intricate mechanisms of immune cells at the maternal-fetal interface, T and B cell development and maturation in offspring, and local immune responses and the role of systemic immunity.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
How to apply
Application links
Required documents
- SF-424 (R&R) Cover Page
- Project Narrative (Research Strategy)
- Budget and Budget Justification
- Biographical Sketch
- Previous Research Support
- Facilities and Resources
- Letters of Support (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.865 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$1,073,967,938
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$719,372,575
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$276,059,721
-
$155,556,396
-
$155,482,198
-
$103,665,364
-
$74,151,078
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$72,701,366
-
$52,238,426
-
$47,450,377
Top States by Funding
- WA 1 awards $1,074.0M
- NC 7 awards $925.9M
- MD 4 awards $501.6M
- MA 3 awards $190.0M
- PA 3 awards $145.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.865). How funding has trended year over year.
| 2024 | $1,282,226,682 | |
| 2025 | $1,333,391,690 | |
| 2026 est. | $184,920,723 |
FAQ
Who can apply for this R01 grant?
Eligible organizations include academic institutions, research hospitals, nonprofits, and federal laboratories. Individuals must have research doctorate and relevant research experience.
What is the deadline?
The application deadline is November 5, 2028. Applications open December 30, 2024.
Can I propose clinical trials?
Yes, clinical trials are optional. You may propose basic research, clinical research, or combination approaches.
How competitive is this grant?
R01 grants are highly competitive. Strong preliminary data and innovative research questions are essential.
What is the typical funding range?
R01 grants typically fund $250,000-$500,000 annually for 3-5 years. Actual amounts vary by field and scope.
💡 Tips for applicants
- Secure strong preliminary data demonstrating feasibility before submitting your application.
- Align your research questions with NIH priorities in immunology and developmental biology.
- Include detailed timelines and milestones for each specific aim.
- Involve experienced collaborators if your team lacks relevant expertise.
- Address potential limitations and competing research head-on in your narrative.
⚠️ Common mistakes
Weak or insufficient preliminary data demonstrating research feasibility. Unclear research aims or overly ambitious scope that cannot realistically be completed in funding period. Misalignment with current NIH scientific priorities in immunology research.
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