Early Immune System Development and Ontogeny (R01 Clinical Trial Optional)

The Early Immune System Development and Ontogeny grant offered by the National Institutes of Health (NIH), under the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), aims to advance research into the mechanisms of immune system development during early life. This funding opportunity supports studies focusing on the prenatal and postnatal development of immune functions in infants, children, and adolescents, with particular attention to those with or without in-utero exposure to HIV and anti-retroviral therapeutics (ART). The initiative emphasizes understanding the maternal-fetal immune interface, T and B cell development, systemic and local immune responses, and the effect of chronic maternal and paternal infections on immune development. NICHD’s broader mission is to promote the health of children and families by investigating human development, reproductive health, and pediatric and adolescent well-being. Through this grant, NICHD seeks to uncover how immune ontogeny is influenced by exposure to infections like HIV, immunosuppressive factors, and associated co-morbidities. This supports their long-term goals of reducing childhood morbidity and mortality, restoring health, and enhancing quality of life through research and training. Eligible projects may investigate immune system development through various lenses, including epigenetic factors such as DNA methylation, the maternal-fetal interface’s role in immune imprinting, organ-specific immunity, and the impact of early-life exposure to vaccines or immuno-therapeutics. Notably, the scope must maintain relevance to infectious diseases and early immune system development. Applications that focus solely on vaccine advocacy, microbiome effects unrelated to immunity, or epigenomics without linking to immune development are deemed non-responsive. Applications may request up to $400,000 annually in direct costs for a maximum of four years. The grant allows both clinical trial and non-clinical trial proposals and is open to a wide array of organizations, including U.S. and non-U.S. higher education institutions, nonprofits, government entities, and for-profit organizations. Foreign organizations and components are also eligible. Applications must be submitted through the NIH’s ASSIST system, institutional system-to-system tools, or Grants.gov Workspace, and must comply with the NIH Application Guide and any NOFO-specific instructions. The funding opportunity was reissued as PAR-25-362 and includes several standard NIH application due dates specific to AIDS-related research. Upcoming deadlines include May 7, 2026; October 5, 2026; February 5, 2027; and others through 2028. The final expiration date is November 6, 2028. Applications are reviewed on scientific merit, rigor, innovation, feasibility, and investigator expertise. There are no cost-sharing requirements, and awards are contingent on the availability of NIH funds and the submission of high-quality proposals. For technical and scientific inquiries, applicants are encouraged to contact Dr. Sai Majji at [email protected] or by phone at 301-661-9816. Grants management questions can be directed to Mindy Bixby at [email protected] or 301-402-3204. Additional assistance is available through eRA Commons or Grants.gov support lines. All applicants should review the full Notice of Funding Opportunity thoroughly to ensure compliance with the detailed requirements prior to submission.

Review NOFO updates and contact the scientific officer before submission to confirm responsiveness; ensure Data Sharing Plan compliance.