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

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has announced the funding opportunity Early Immune System Development and Ontogeny (R01 Clinical Trial Optional) under funding opportunity number PAR-25-362. This initiative seeks to advance understanding of the mechanisms driving immune system development in utero, during early postnatal life, and throughout early childhood, focusing on neonates, infants, children, and adolescents. Research may include populations with or without in-utero exposure to HIV or antiretroviral therapeutics (ART). The goal is to elucidate the roles of maternal and paternal immune status, the maternal-fetal interface, and the impact of genetic, environmental, and epigenetic factors on immune system ontogeny. The funding opportunity emphasizes multidisciplinary research exploring T and B cell differentiation, maturation, and suppression, the development of mucosal immune systems, secondary lymphoid organs, and organ-specific versus systemic immunity. Investigators are encouraged to address maternal and paternal immune influences on immune system programming, including the role of DNA methylation patterns and epigenetic modulation. The announcement highlights the use of advanced technologies, such as single-cell RNA sequencing, imaging, and cytometric profiling, to study immune mechanisms at a cellular level. Research exploring the impact of background immunization, maternal-fetal immune exchanges, and their association with autoimmune diseases during the life course is also encouraged. Applications focused solely on vaccine advocacy, microbiome effects without infectious disease relevance, or exclusively epigenomic approaches will be considered non-responsive. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, tribal governments, and foreign organizations. Non-domestic entities and foreign components of U.S. organizations are eligible to apply. Applicants must complete registrations with SAM.gov, NATO Commercial and Government Entity (NCAGE) Code (for foreign entities), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov. Principal Investigators must have an active eRA Commons account. Application budgets are limited to $400,000 per year in direct costs, excluding consortium Facilities and Administrative (F&A) costs, with a maximum project period of four years. Applicants requesting $500,000 or more in direct costs in any year must contact the NICHD Scientific/Research Contact at least six weeks before submission. Applications will be reviewed based on significance, innovation, rigor, feasibility, investigator expertise, and institutional resources. Additional considerations include protections for human subjects, vertebrate animal welfare, biohazards, and resource sharing plans. Plans for addressing diversity in participant recruitment, retention, and inclusion will also be evaluated. The earliest submission date is April 7, 2025, with recurring standard AIDS application due dates through January 7, 2029. Scientific merit reviews will occur in July, November, and March cycles, with corresponding Advisory Council reviews in October, May, and January. Awards are anticipated to begin in December, July, and April, respectively. Applicants are encouraged to contact the listed scientific, peer review, and grants management representatives for guidance. Compliance with NIH policies, including data management and sharing requirements, is mandatory. Final reporting requirements include Research Performance Progress Reports (RPPR), invention statements, and expenditure data in the Federal Financial Report.