Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed) | RFA AI 20 078

Opportunity Information: Apply for RFA AI 20 078

The Immune Development in Early Life (IDEaL) funding opportunity (RFA-AI-20-078) is a National Institutes of Health (NIH) cooperative agreement (U19) designed to support multidisciplinary research on how the human immune system is established, shaped, and sustained from birth through childhood (up to, but not including, age 18). The core goal is to move beyond broad descriptions of pediatric immunity and instead define the underlying biological mechanisms that drive immune ontogeny and immune function during early life, a period when immune responses can differ substantially from those of adults and when lifelong immune trajectories are often set.

A central scientific emphasis is understanding how exposures common in childhood influence immune development. This includes the effects of pathogenic microbes (infections), non-pathogenic microbes (including commensal organisms and the broader microbiome), and routine or experimental vaccination against infectious diseases. It also explicitly includes non-infectious influences that are increasingly linked to immune-mediated disease risk, such as exposure to allergens and environmental pollutants. Projects supported under this announcement are expected to clarify how these exposures interact with developing immune pathways, potentially explaining why some children develop protective immunity while others become vulnerable to infections, allergic disease, asthma, or other immune-mediated conditions.

The program is structured to encourage genuine collaboration across multiple fields that rarely operate in a single research silo. NIH is seeking integrated teams that may include immunologists, neonatologists, pediatricians, systems biologists, and microbiologists, among others, with the intent of combining clinical insight, advanced immunologic profiling, and computational or systems-level approaches. The cooperative agreement mechanism signals that NIH anticipates substantial programmatic involvement, coordination, and cross-project synergy, rather than isolated investigator-led projects. While the announcement is not a clinical trial mechanism ("Clinical Trial Not Allowed"), it still supports research that can be clinically relevant, such as observational studies, mechanistic studies using biospecimens, and systems immunology approaches, as long as they do not meet the NIH definition of a clinical trial.

From an impact standpoint, the anticipated payoff is practical as well as foundational. By identifying mechanisms that govern immune maturation and how they are altered by early exposures, findings from IDEaL are expected to inform better strategies for pediatric vaccine design (including timing, formulation, and adjuvant selection) and to guide development of immunotherapies tailored to children. The longer-term vision is improving prevention and treatment of both infectious diseases and immune-mediated diseases in a population that is biologically distinct from adults and often underrepresented in mechanistic immunology research.

Eligibility is broad and includes many U.S.-based organization types: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; Native American tribal governments (federally recognized); public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant categories such as 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, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined under the NIH Grants Policy Statement, enabling meaningful international collaboration when it strengthens the science.

Administratively, the opportunity sits within NIH’s health and environment research categories and lists CFDA numbers 93.113 and 93.855. The award ceiling is noted as $1,000,000. The original closing date was June 18, 2021, and the funding opportunity was created January 12, 2021.

• The National Institutes of Health in the environment, health sector is offering a public funding opportunity titled "Immune Development in Early Life (IDEaL) (U19 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): 93.113, 93.855.
• This funding opportunity was created on 2021-01-12.
• Applicants must submit their applications by 2021-06-18. (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 $1,000,000.00 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.

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