Early Immune System Development and Ontogeny (R01 Clinical Trial Optional) | PAR 25 362

Opportunity Information: Apply for PAR 25 362

The Early Immune System Development and Ontogeny (R01 Clinical Trial Optional) funding opportunity (PAR-25-362) is a National Institutes of Health (NIH) research grant aimed at clarifying how the immune system is formed and shaped from pregnancy through early life. The focus is on immune development in utero, during the early post-natal period, and throughout early childhood, covering neonates, infants, children, and adolescents. A central theme is comparing immune development in offspring with and without in-utero exposure to HIV or antiretroviral therapeutics (ART), since those exposures may influence immune maturation, immune regulation, and vulnerability or resilience to infection and other immune-related outcomes.

The scientific scope emphasizes mechanistic work on early-life immune ontogeny, including what happens at the maternal-fetal interface where maternal and fetal immune systems interact. Projects are encouraged to examine how immune cells behave and communicate in that setting, how early immune environments may program later immune responses, and how these processes differ depending on HIV and/or ART exposure. The NOFO also highlights T and B cell development and maturation in offspring, pointing applicants toward studies that can unpack how adaptive immunity is established, how immune repertoires evolve, and which developmental checkpoints or pathways may be altered by prenatal exposures. In addition, the opportunity calls attention to local immune responses and their relationship to systemic immunity, supporting work that connects tissue-level immunity (for example at barrier sites) with circulating immune function to explain early-life immune competence.

This is an R01 mechanism, meaning it supports discrete, hypothesis-driven research projects with the scale and rigor expected of a standard NIH research grant. The announcement is labeled “Clinical Trial Optional,” which typically means applicants may propose studies that include clinical trial elements if scientifically necessary, but they are not required to run a clinical trial to be responsive. In practice, this leaves room for a range of human-focused study designs, from observational cohorts and intensive immune profiling to interventional approaches where appropriate, as long as the work stays aligned with the goal of understanding mechanisms of early immune development.

Eligibility is broad. In addition to common NIH-eligible applicant types (including state, county, and city governments; special districts; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other eligible entities), the NOFO explicitly names several additional eligible applicant categories. These include 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, and non-U.S. entities (foreign organizations) and regional organizations. The explicit listing signals an intent to encourage broad participation, including institutions and communities that may be well positioned to study diverse populations affected by HIV exposure, ART exposure, and related maternal-child health contexts.

Key administrative details provided in the source data include the awarding agency (NIH), the activity area (Health, Income Security and Social Services), and CFDA number 93.865. The opportunity is listed with an award ceiling of $400,000, and an original closing date of 2029-01-07, indicating a multi-year window during which applications may be accepted across multiple receipt dates under the parent announcement structure. Overall, this NOFO is designed to push the field toward a clearer, more integrated understanding of how early immune systems are built, how maternal and prenatal factors shape that process, and how those early immune trajectories may differ in the setting of HIV and/or ART exposure.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Early Immune System Development and Ontogeny (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2024-12-30.
• Applicants must submit their applications by 2029-01-07.
• Each selected applicant is eligible to receive up to $400,000.00 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 PAR 25 362

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