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

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), is offering a funding opportunity titled "Early Immune System Development and Ontogeny (R01 Clinical Trial Optional)." This opportunity, issued under the NIH’s R01 Research Project Grant mechanism, seeks to further explore and understand early immune system development. It specifically focuses on ontogeny during fetal development, postnatal infancy, and early childhood stages in neonates, infants, and children, both with and without in-utero exposure to HIV or Anti-Retroviral Therapeutics (ART). The initiative aligns with NICHD’s overarching mission to improve reproductive health, enhance childhood and adolescent development, and optimize life outcomes for all individuals through cutting-edge research and training. The research funded through this Notice of Funding Opportunity (NOFO) should delve into maternal and paternal influences on immune development, especially in the context of HIV and related co-morbidities. The NOFO encourages studies on immune cell differentiation, maturation of T and B lymphocytes, and the formation of mucosal and systemic immunity in early life. The opportunity welcomes multidisciplinary approaches that examine parental DNA methylation, epigenetic influences, immunological imprinting at the maternal-fetal interface, and the role of factors such as microbiomes, diet, and metabolism on pediatric immune responses. Applications that solely focus on vaccine advocacy or isolated microbiome or epigenomic research without context to immune development will be considered non-responsive. This NOFO supports both clinical and non-clinical research and permits applications proposing clinical trials. It allows for new, resubmission, and revision applications. The maximum project period is four years, and budgets are capped at $400,000 in direct costs per year, excluding consortium F&A costs. Applications requesting $500,000 or more in any year must contact a Scientific/Research Contact at least six weeks before submission. All applications must follow NIH’s stringent application and submission protocols, as outlined in the SF424 (R&R) Application Guide and include a comprehensive Data Management and Sharing Plan. Applications may be submitted via ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. All key personnel, including Program Directors/Principal Investigators, must have eRA Commons accounts and comply with all system registration requirements including SAM, NCAGE (if foreign), and Grants.gov. All applications are due by 5:00 PM local time on the designated due date, and applicants are advised to apply early to address potential submission errors. The recurring submission dates for this funding opportunity follow the NIH standard schedule for AIDS-related applications, with upcoming due dates including May 7, 2026, January 7, 2027, and beyond, through January 7, 2029. The current expiration date for this NOFO is set to May 8, 2026. Submitted applications will undergo scientific merit review and advisory council review prior to awards, which are anticipated to begin approximately six months after submission. The review process will emphasize significance, innovation, scientific rigor, feasibility, and investigator expertise. For scientific inquiries, applicants are encouraged to contact Dr. Sai Majji (sai.majji@nih.gov, 301-661-9816), and for grants management questions, Mindy Bixby (mindy.bixby@nih.gov, 301-402-3204) is available. Applications should adhere closely to submission and review guidelines to avoid delays or rejections. The NOFO outlines comprehensive instructions regarding allowable costs, mandatory registrations, and evaluation metrics, providing ample support for applicants committed to advancing the science of pediatric immunity.

Do not submit proposals that focus exclusively on microbiomes, vaccine advocacy, or epigenomics without connection to early immune system development.