Clinical Trials in Organ Transplantation in Children and Adults

The Clinical Trials in Organ Transplantation in Children and Adults program is a federally supported initiative administered by the National Institute of Allergy and Infectious Diseases within the U.S. Department of Health and Human Services. This program reflects the agency’s broader mission to advance scientific knowledge and improve public health outcomes, particularly in areas involving immune-mediated diseases and complex clinical interventions. Through this opportunity, the agency seeks to strengthen the national research infrastructure supporting transplantation science and to promote innovative, collaborative clinical trials that address critical gaps in patient outcomes. The primary purpose of this funding opportunity is to support multicenter clinical trials that aim to improve the success and long-term outcomes of organ transplantation in both pediatric and adult populations. The program emphasizes the integration of mechanistic studies alongside clinical trials to better understand immune responses and transplant biology. Areas of focus include transplantation of major organs such as heart, lung, kidney, liver, and intestines, as well as emerging fields like vascularized composite tissue transplantation and non-hematopoietic cellular therapies. The initiative also extends to the use of bone marrow, mesenchymal stem cells, and other immunologically active cells as adjunct therapies to improve transplant success. Funding will be provided through cooperative agreements, indicating a substantial level of involvement from the funding agency in the execution and oversight of funded projects. While specific allowable cost categories are not explicitly detailed in the forecast, funding is expected to support the full scope of clinical trial activities, including patient enrollment, data collection, laboratory analyses, and coordination across multiple sites. There is no requirement for cost sharing or matching funds, which may broaden accessibility for eligible applicants. The total estimated program funding is significant, reflecting the complexity and scale of the supported research. Eligibility for this opportunity is broad and inclusive, encompassing a wide range of organizational types. Eligible applicants include state and local governments, tribal entities, institutions of higher education (both public and private), nonprofit organizations with or without 501(c)(3) status, small and large for-profit organizations, and certain federal agencies. Additionally, foreign institutions and regional or community-based organizations may be eligible, depending on specific program guidance. This inclusivity is intended to encourage diverse participation and foster collaborative research efforts across sectors and geographies. The application process will follow standard federal grant submission procedures, likely requiring registration in systems such as Grants.gov and submission of a comprehensive application package. While specific application components are not detailed in the forecast, applicants can expect to provide detailed research plans, clinical protocols, budgets, and supporting documentation demonstrating organizational capacity and expertise. Evaluation criteria will likely focus on scientific merit, feasibility, innovation, and the potential impact on transplant outcomes. This opportunity is currently in the forecast stage, with an estimated application due date of September 30, 2027, and anticipated awards issued by July 1, 2028. Projects are expected to begin shortly thereafter. The program appears to be part of an ongoing federal research initiative, suggesting potential recurrence or continuation in future funding cycles. Interested applicants are encouraged to monitor updates and prepare early, particularly given the complexity of multicenter clinical trial proposals. For inquiries, applicants may contact the program leadership via the provided email address.