Immune Tolerance Network (UM1 Clinical Trial Required) | RFA AI 19 068

Opportunity Information: Apply for RFA AI 19 068

The Immune Tolerance Network (UM1 Clinical Trial Required) funding opportunity (RFA-AI-19-068) is a National Institutes of Health cooperative agreement designed to support a coordinated, multi-site clinical research network focused on developing and testing ways to induce and sustain immune tolerance in people. The central aim is to move beyond broadly immunosuppressive strategies and instead evaluate approaches that can retrain or recalibrate immune responses to prevent or treat disease. The Network concentrates on three main clinical areas: asthma and allergic diseases, autoimmune diseases, and immune-mediated complications of allotransplantation (such as transplant rejection and related immune effects).

A major emphasis of the program is the design and execution of clinical trials across all phases, meaning applicants are expected to be able to plan and run early-stage through later-stage trials that assess both safety and efficacy of investigational products or other tolerance-inducing interventions. These trials are not intended to be purely clinical outcome studies; they are expected to be tightly integrated with mechanistic research that helps explain how and why an intervention works (or does not work). In practice, this means the Network’s trials should include immune monitoring, biomarker development, and other translational components aimed at measuring tolerance-related processes in humans.

In addition to running trials, the Network is expected to build and manage the supporting scientific infrastructure needed for tolerance research at scale. This includes conducting mechanistic studies and developing, standardizing, and applying tolerance assays as core elements of the clinical trial programs. It also includes establishing and overseeing a consortium of laboratories and creating and/or managing one or more biospecimen repositories so that samples collected during trials can be processed consistently, stored appropriately, and made usable for current and future analyses. The FOA also calls for strong bioinformatics and data capabilities, including systems for data collection, validation, management, and statistical analysis, reflecting the expectation that the Network will generate complex clinical and immunologic datasets that must be handled in a high-quality, reproducible way.

While the focus is clearly on human clinical evaluation, the FOA allows limited support for focused product development and selected nonclinical studies when they are essential to enable subsequent human testing of promising tolerance-inducing approaches. Examples mentioned include toxicology, pharmacology, and pharmacokinetics, which are often required to clear key regulatory or safety hurdles before an intervention can be evaluated in people. This allowance is framed as selective and enabling rather than a primary purpose, reinforcing that the Network’s core deliverable is well-designed clinical research with integrated mechanistic insight.

From an administrative standpoint, this opportunity uses the UM1 activity code and is issued as a cooperative agreement, which typically means NIH anticipates substantial programmatic involvement during the award period compared with a standard research project grant. The opportunity is categorized under health (CFDA 93.855) and was created on December 6, 2019, with an original closing date of March 3, 2020.

Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Historically Black Colleges and Universities, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. Foreign institutions and other non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S.-based applicant may include certain defined international collaborations or activities as part of the overall project when permitted under NIH policy.

Overall, the opportunity is aimed at supporting a full-spectrum, trial-driven tolerance research enterprise: selecting or developing promising tolerance strategies, testing them rigorously in humans through phased clinical trials, embedding deep mechanistic and biomarker work within those trials, and maintaining the lab, biorepository, and informatics backbone needed to make the resulting data and biospecimens maximally informative and reusable for advancing immune tolerance science.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Immune Tolerance Network (UM1 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2019-12-06.
• Applicants must submit their applications by 2020-03-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AI 19 068

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