Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council’s input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find NIAID initiatives, go to Explore NIH Grant Opportunities.
Note: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
Fiscal Year (FY) 2028 Division of Allergy, Immunology, and Transplantation (DAIT) Concepts
- Clinical Data, Safety and Statistical Centers (CDSSC)
- Immune Tolerance Network (ITN)
- Translational Transplantation Tolerance Cooperative Study Group (TTTCSG)
- Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA)
- Childhood Asthma in Urban Settings Clinical Research (CAUSE) Network
- Asthma and Allergic Diseases Cooperative Research Centers (AADCRC)
Clinical Data, Safety and Statistical Centers (CDSSC)
For more information, go to View Grant Opportunity for Clinical Data, Safety and Statistical Centers (CDSSC). Note: Information is tentative and subject to change.
Request for Applications—proposed FY 2028 initiative
Contact:
Leighton Thomas
Objective: The objective of this initiative is to provide coordination and oversight for multiple activities in service to clinical research and mechanistic studies supported by NIAID.
Description: This initiative will provide a broad range of support critical for the design, development, implementation, and analysis of clinical research carried out by multiple Division-supported programs in three disease areas: asthma and allergy, autoimmune diseases, and transplantation. The support to be provided includes statistical design and analysis, protocol development, study initiation and management, data management, safety monitoring, sample tracking, final analysis of study findings and manuscript development.
Immune Tolerance Network (ITN)
For more information, go to View Grant Opportunity for Collaborative Network for Clinical Research on Immune Tolerance. Note: Information is tentative and subject to change.
Request for Applications—proposed FY 2028 initiative
Contact:
Leighton Thomas
Objective: The objective of this initiative is to enhance understanding of the underlying mechanisms of the induction, maintenance, and loss of immune tolerance in humans, and to develop improved tolerogenic interventions for the prevention and treatment of immune system mediated diseases (including transplant rejection, autoimmune diseases, and asthma and allergic diseases).
Description: This initiative will renew NIAID's successful Immune Tolerance Network (ITN), a consortium of basic and clinical scientists that: (1) develops a scientific agenda for clinical trials and mechanistic studies of various approaches to tolerance induction; (2) designs and conducts clinical trials at all phases to determine the feasibility, safety, toxicity, and efficacy of tolerogenic intervention strategies for multiple immune system diseases; (3) designs and conducts research to delineate the underlying mechanisms of immune tolerance in conjunction with clinical trials undertaken by the ITN as well as research projects sponsored by other Federal and private sector organizations and companies; and (4) develops, tests and validates assays to measure the induction, maintenance and loss of immune tolerance in humans. For this initiative, tolerance is broadly defined as specific lack of an immune response to targeted antigens (e.g., alloantigens, autoantigens, or allergens) by any of a variety of approaches including deletion, induction of anergy, immune deviation, sequestration, or suppression. Approaches may target antigen-specific receptors, molecules of the costimulation pathways, homing molecules, or other relevant approaches, and may use any of a variety of agents including antigen, peptides, altered peptides, monoclonal antibody blockade, cytokines, cellular therapies, molecularly engineered cells or tissues, DNA vectors, or other relevant molecules.
Translational Transplantation Tolerance Cooperative Study Group (TTTCSG)
For more information, go to View Grant Opportunity for Translational Transplantation Tolerance Cooperative Study Group. Note: Information is tentative and subject to change.
Request for Applications—proposed FY 2028 initiative
Contact:
Julia Shaw
Objective: This initiative will enable the establishment of a multi-center, cooperative program dedicated to developing, optimizing, and evaluating approaches to induce and maintain immune tolerance to allogeneic transplants which will be tested in translationally relevant models. The overarching goal is to facilitate clinical translation of safe and effective transplant tolerance regimens that achieve long-term graft survival without the need for life-long administration of immunosuppressive drugs.
Description: This initiative will support research projects seeking to develop clinically translatable approaches for inducing and maintaining tolerance to allogeneic islet, kidney, heart, liver, intestinal, and/or lung transplants. Approaches may vary, however, the research objectives must incorporate (1) in vivo safety and efficacy assessment of one or more novel tolerogenic approaches and/or refinements of existing regimens in a translational model (i.e., a model system that mimics the relevant aspects of human immune responses to a transplant with sufficient fidelity to predict the efficacy and safety of potential clinical therapies), and (2) accompanying immunologic studies to elucidate the cellular and/or molecular mechanisms leading to tolerance or the lack thereof.
The initiative will not support extensive model development. Use of an established nonhuman primate (NHP) model is encouraged but not required. If another model is proposed, the applicant must provide evidence that the experimental model is well-developed and routinely accepted by the US Food and Drug Administration (FDA) as sufficient for generating investigational new drug (IND)-enabling data in transplantation. The initiative supports and encourages use of new approach methodologies (NAMs) for refining approaches prior to testing in NHP or other translational models. Limited use of small animal models for further refinement is also allowed if well-justified. Additional objectives related to the tolerogenic approach or mechanistic studies may be proposed as long as the primary focus of the application meets the above basic requirements. Additional objectives may include:
- Assessment of alternative transplantation sites for pancreatic islets.
- Measures to improve the safety and/or tolerability of various tolerogenic approaches.
- Optimization of immunosuppression reduction and/or timing of therapeutic interventions to successfully enable complete immunosuppression withdrawal.
- Development, evaluation, and validation of biomarkers or other novel means for predicting or assessing the induction, maintenance, loss, and/or lack of immune tolerance and/or onset of acute or chronic graft rejection.
An Infrastructure and Opportunities Fund (IOF) will be established as part of the cooperative study group to support emerging opportunities through short-term pilot or feasibility projects that are within the scope of the initiative.
Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA)
For more information, go to View Grant Opportunity for Clinical Trials in Organ Transplantation in Children and Adults. Note: Information is tentative and subject to change.
Request for Applications—proposed FY 2028 initiative
Contact:
Megan Morsheimer
Objective: This initiative will support clinical trials (Phase 1, 2, or 3) in organ transplantation with associated studies of human immune mechanisms. The goal of this initiative is to improve the outcome of organ transplantation by (1) evaluating innovative therapies that will increase graft survival while decreasing medication-induced injury; (2) identifying and validating biomarkers of immune activation, immune quiescence, and pending graft injury in urine, blood, or tissue samples that will allow individualization and optimization of anti-rejection therapy; and (3) evaluating the use of cell transplantation, limited to (a) transplantation of immunologically active cells such as regulatory T cells, regulatory dendritic cells, and others to modify the immune response to the allograft, and (b) transplantation of metabolically active cells such as pancreatic islets, hepatocytes, and others as an alternative to whole organ transplantation. All clinical trials must be accompanied by a program of studies of immune mechanisms using human specimens that will increase our understanding of allograft rejection, injury and/or survival, or of immunologic tolerance.
Description: This initiative will support multicenter clinical trials, with associated studies of immune mechanisms, in heart, lung, kidney, liver, and intestinal transplantation. Clinical trials of nonhematopoietic cellular transplantation as replacement therapies; vascularized composite tissue transplantation; and transplantation of bone marrow or mesenchymal stem cells, or of immunologically active cells, as adjuncts to organ transplantation will be allowed. This initiative is a renewal of RFA-AI-20-029, which supports investigators to use novel trial designs in which therapies are evaluated sequentially, first in adults and then children, and enhances overall enrollment in studies in which the success of a therapy or biomarker is not associated with age. The initiative will include an Ancillary Studies Fund to support studies using human specimens from CTOT-CA or other clinical trials, including basic studies of alloimmunity; development of new immunologic assays; and the purchase of laboratory equipment to facilitate immunologic mechanistic studies associated with clinical trials implemented under this initiative. Investigators will be encouraged to include new and junior investigators to participate in both the Ancillary Studies Fund projects and clinical trials. To accommodate anticipated study initiation activities, all clinical trials will be expected to enroll and complete follow-up on all participants within five years. In addition to a clinical trial and its companion mechanistic studies, applicants will be asked to propose a second project (ancillary mechanistic study or completion/extension of existing eligible clinical trial) that can be completed in the first two years of the funding period.
Childhood Asthma in Urban Settings Clinical Research (CAUSE) Network
For more information, go to View Grant Opportunity for Childhood Asthma in Urban Settings Clinical Research Network. Note: Information is tentative and subject to change.
Request for Applications—proposed FY 2028 initiative
Contact:
Patrice Becker
Objective: This initiative will support a cooperative multi-center network to develop and test innovative hypotheses and strategies for the prevention and treatment of asthma in children living in urban environments.
Description: The CAUSE Network will support multi-site clinical studies and trials and translational studies to support novel approaches for the prevention and treatment of asthma in economically disadvantaged pediatric populations with a high disease burden. The Network will be composed of a Leadership Center (CAUSE-LC) and up to 7 Clinical Research Centers (CAUSE-CRCs). The CAUSE-LC will provide the overall operational strategy, issue highly specialized subawards to support mechanistic research, direct patient engagement strategies, and interact closely with the CAUSE-CRCs to support and direct the conduct of multi-site clinical studies and trials. A Steering Committee composed of CAUSE-LC and CAUSE-CRC PD/PIs will evaluate clinical proposals to select studies and/or trials. The CAUSE-CRCs will implement the Network trials and studies.
Asthma and Allergic Diseases Cooperative Research Centers (AADCRC)
For more information, go to View Grant Opportunity for Asthma and Allergic Diseases Cooperative Research Centers. Note: Information is tentative and subject to change.
Request for Applications—proposed FY 2028 initiative
Contact:
Patrice Becker
Objective: This initiative will support programs conducting integrated clinical and translational research on the immune mechanisms of asthma, rhinitis, chronic rhinosinusitis, atopic dermatitis, food allergy, drug allergy, and urticaria/angioedema, as well as understudied diseases such as alpha-gal syndrome, eosinophilic GI disease, and food protein-induced enterocolitis (FPIES). The overarching goals of the AADCRC program are to improve understanding of the pathogenesis of these conditions and generate novel data that provide a foundation for new, effective treatments and/or disease prevention strategies.
Description: The focus of the AADCRC program is on human disease, with the proposed research defined as human subjects research or research utilizing human material (including primary human cells, biologic samples, and clinical data). Programs may (1) propose multiple approaches focused on an immunologic mechanistic pathway relevant to one of the diseases of interest, or (2) be centered around one or more observational studies or single-site pilot clinical trials testing a central hypothesis. The AADCRC centers coordinate their efforts through a Steering Committee and an opportunity fund that supports pilot projects from early-stage investigators at the funded centers or collaborative projects across sites.