Funding News Edition: February 16, 2022 See more articles in this edition
Do you have experience in nonhuman primate (NHP) transplant models? Could your research facilitate clinical translation of safe and effective approaches to reduce or eliminate dependence on immunosuppressive drugs for long-term allograft acceptance? If so, consider applying for Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) funding through two recently reissued funding opportunity announcements (FOAs):
- Nonhuman Primate Transplantation Tolerance Cooperative Study Group (U01, Clinical Trial Not Allowed)
- Nonhuman Primate Transplantation Tolerance Cooperative Study Group (U19, Clinical Trial Not Allowed)
Research Objectives and Scope
Organ transplants are the preferred treatment in many end-stage organ diseases when other therapies have failed. While one-year graft survival rates for most organ transplants are now at or exceed 90 percent, long-term graft and patient survival remains suboptimal due to short- and long-term allograft failure.
The goal of this initiative is to support research projects that use NHP models of allogenic islet, kidney, heart, liver, intestine, or lung transplants to 1) develop novel immune tolerance induction regimens, 2) evaluate the preclinical safety and efficacy of existing and newly developed candidate immune tolerance induction regimens, 3) develop and validate biomarkers for induction, maintenance, or loss of immune tolerance or for prediction of graft survival, and 4) elucidate mechanisms underlying induction, maintenance, or loss of transplant tolerance.
Your application must include:
- One or more novel tolerogenic approach(es)
- In vivo safety and efficacy assessment of novel immune tolerance induction regimens or refinements/modifications of existing regimens in NHP models
- Accompanying mechanistic or biomarker studies
- Elucidation of the underlying immunologic mechanisms responsible for or contributing to induction, maintenance, loss, or lack of immune tolerance achieved by the regimen tested in vivo
- Development, evaluation, and validation of biomarkers or other novel means for predicting or assessing the induction, maintenance, loss, or lack of immune tolerance or onset of acute or chronic graft rejection
You may propose additional objectives related to the tolerogenic approach and mechanistic studies, such as the development of immune-modulating agents (as needed), alternative transplantation sites for pancreatic islets or measures to improve the safety or tolerability of the tolerogenic approaches tested, but the primary focus of your application must address the basic requirements listed above.
Applications must include realistic, clear, and quantitative annual milestones that will help NIAID program staff assess annual progress and support funding decisions.
Infrastructure and Opportunity Fund
Your application budget should allocate resources for an Infrastructure and Opportunity Fund (IOF) to capitalize on emerging opportunities consistent with the goals of NHPCSG. The application must also include an IOF Management Plan, either as an attachment to a U01 application or as part of the IOF Management Core component for a U19 application.
Refer to the FOAs for requirements specific to the IOF and its management.
Nonresponsive Application Areas
NIAID will consider applications proposing the following research areas to be nonresponsive and will not review them:
- Studies in animal models other than NHPs, unless used solely as an in vivo assay to assess the NHP immune response
- Human subjects research, although use of human specimens in confirmatory or comparative assays is allowed
- Clinical trials (all phases)
- Preliminary development of an NHP transplantation model (e.g., surgical techniques for reliable post-operative recovery and initial allograft function while on standard immunosuppression)
- Studies with a primary focus on improving isolation, preservation, or supply of organs, tissues, or cells
- Hematopoietic cell transplantation, unless proposed in the context of islet or organ transplantation (i.e., optimization of bone marrow chimerism approaches for tolerance induction is allowed)
- Transplantation of any organs or tissues other than pancreatic islet, kidney, heart, lung, liver, or intestine, unless performed in the context of islet or organ transplantation (i.e., multivisceral transplantation or thymic tissue transplantation as a means of tolerance induction is allowed)
- Studies of non-specific side effects of an immunomodulatory agent (e.g., drowsiness, fatigue, constipation)
- Studies focused on HIV/AIDS-related research
Submission and Contact Information
All applications are due on or before May 13, 2022, by 5 p.m. local time of the applicant organization.
Application budgets are not limited but should reflect the actual needs of the proposed project. As guidance, note that annual direct costs for previous NHPCSG awardees averaged $570,000 for U01 awards and ranged from $900,000 to $2,400,000 for U19 awards, excluding the Infrastructure and Opportunity Fund.
The scope of the proposed project should determine the project period, which should not exceed five years.
If you have questions about the responsiveness of your application, direct your inquiries to Dr. Julia Shaw, NIAID’s scientific/research contact listed for these initiatives, at 240-627-3711 or email@example.com. For questions about peer review for the FOAs, contact Dr. Tara Capece at 301-761-7854 or firstname.lastname@example.org.