Nonhuman Primate Transplantation Tolerance (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Nonhuman Primate Transplantation Tolerance (U01) funding opportunity?

It is a National Institute of Allergy and Infectious Diseases (NIAID) cooperative agreement (U01) funding opportunity, identified as RFA AI 16 007, that supports a coordinated, multi-center research effort focused on transplantation tolerance in nonhuman primate (NHP) models.

Which federal organizations are responsible for this opportunity?

The opportunity is issued under the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), and is specifically administered through NIAID. The issuing agency is listed as HHS-NIH11.

What is the main purpose of this program?

The program is intended to create and sustain a collaborative structure that enables rigorous, translationally oriented preclinical studies in NHP models, with the goal of realistically informing and accelerating improvements in human clinical transplantation.

What collaborative structure does this opportunity support?

It creates and sustains the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG), which is designed to function as an integrated, coordinated program rather than a set of isolated projects.

What does it mean that this is a Cooperative Agreement (U01) rather than a standard research grant?

A U01 cooperative agreement typically involves substantial scientific or programmatic involvement by NIH compared to a standard research project grant. In practice, funded teams are expected to work within a cooperative framework, participate in coordinated group activities, and align with program priorities to help the NHPCSG operate as a unified effort.

What research models are the focus of this program?

The program focuses on nonhuman primate (NHP) models of transplantation, positioned as a critical bridge between early experimental work and human clinical trials because NHP immune systems and transplant biology often mirror key aspects of human transplantation more closely than rodent models.

Which transplant settings are specifically targeted?

The program targets four major transplant settings: kidney transplantation, pancreatic islet transplantation, heart transplantation, and lung transplantation.

Why are these transplant areas prioritized?

These settings are prioritized because long-term graft survival remains limited by immune rejection and the toxicity associated with chronic immunosuppression.

What are the near-term scientific goals of the NHPCSG?

The near-term goals are (1) to evaluate the preclinical safety and efficacy of immune tolerance induction regimens (including established and newly developed strategies), and (2) to clarify the mechanisms that explain how tolerance is induced, maintained over time, and why it sometimes fails or is lost.

What kinds of interventions or approaches are expected to be studied?

The focus is on immune tolerance induction regimens, including both established approaches and newly developed strategies, evaluated for safety and efficacy in NHP transplant models.

Is the program only looking for regimens that improve outcomes, or also for mechanistic understanding?

Both. The program seeks regimens that can induce tolerance in primates and also requires clear biological explanations and measurable correlates that can guide clinical translation, patient selection, monitoring, and risk management.

What is meant by “tolerance” in the context of this opportunity?

In this context, tolerance refers to strategies aimed at achieving long-term graft survival with reduced reliance on chronic immunosuppression, by inducing and maintaining immune acceptance of the transplanted organ or tissue.

What is the long-range objective of the program?

The long-range objective is to develop and test tolerance induction regimens that can produce more durable graft function and improved long-term outcomes in people, ideally reducing the need for lifelong immunosuppression and its associated complications.

How does this opportunity connect preclinical research to human clinical transplantation?

It emphasizes translationally oriented preclinical studies in NHP models, with interventions that have plausible paths toward real-world clinical use, positioning NHP work as a bridge toward trials in patients.

Are single institutions eligible to participate, or is it only for consortia?

The opportunity is designed to bring together both single institutions and multi-institution consortia to conduct coordinated, rigorous preclinical studies.

What expectations are described for collaboration among funded teams?

Funded teams are expected to operate cooperatively by sharing data and resources when appropriate, aligning study designs with group priorities, and participating in coordinated activities that support the NHPCSG as an integrated program.

What is the primary subject area of this funding opportunity?

The opportunity is categorized under Health and focuses on transplantation tolerance research in NHP models.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.855 and 93.856.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations, including: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in that nonprofit category); for-profit organizations other than small businesses; small businesses; and other entities as allowed by the full announcement’s additional eligibility language.

When was this opportunity posted?

The opportunity was posted on April 19, 2016.

What is the application closing date?

The application closing date is August 3, 2016. The provided record indicates that the original and current closing dates are the same.

What is the overarching program emphasis: basic science, applied research, or both?

Both. The program emphasizes outcome-driven evaluation (preclinical safety and efficacy) alongside deep mechanistic work (how tolerance is induced, sustained, and lost), with an explicit endpoint of advancing strategies that can credibly move toward human transplantation.