The Characterization and Discovery of Novel Autoantigens and Epitopes in Type 1 Diabetes (R01 Clinical Trial Optional) | RFA DK 17 031

Opportunity Information: Apply for RFA DK 17 031

The grant opportunity titled "The Characterization and Discovery of Novel Autoantigens and Epitopes in Type 1 Diabetes (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-DK-17-031) is a National Institutes of Health (NIH) discretionary grant focused on advancing research into the immune targets involved in type 1 diabetes. The central aim is to support original, hypothesis-driven studies that identify and characterize previously unrecognized autoantigens and epitopes, with a strong emphasis on "neoantigens" and "neoepitopes" that may arise from processes like post-translational modification, abnormal protein processing, hybrid peptide formation, or other changes that can make self-proteins appear foreign to the immune system. The overall intent is to deepen understanding of what the immune system is reacting to in type 1 diabetes and how those reactions contribute to disease initiation and progression.

A key feature of the announcement is its interest in connecting antigen discovery to immune function. Applicants are encouraged not only to find new candidate targets, but also to characterize the autoimmune responses they provoke, including both humoral immunity (autoantibodies) and cell-mediated immunity (T cell responses). That means proposals could involve defining which immune cells recognize specific neoepitopes, mapping epitope regions and HLA restriction, measuring response magnitude and phenotype, and linking these immune signatures to clinically relevant stages of disease such as pre-symptomatic autoimmunity, onset, or established type 1 diabetes. The FOA frames these efforts as important for clarifying the etiology and pathophysiology of type 1 diabetes, in other words, the causal chain and biological mechanisms that drive beta cell damage and loss.

The announcement also makes it clear that studies should not operate in isolation from what is already known in the field. Projects are expected to integrate new findings with established antigens and epitopes commonly used in type 1 diabetes research and risk prediction, explicitly referencing well-known autoantibody targets such as insulin, GAD65, IA-2, and ZnT8. In practice, this signals an expectation that proposed work will situate novel antigen or epitope candidates alongside the current framework used for understanding disease heterogeneity, staging, biomarkers, and immune monitoring. Integration could include comparisons to known antibody or T cell reactivities, determining whether neoepitope responses precede or follow classic autoantibody appearance, or assessing whether novel targets help explain cases that are not well captured by established markers.

Mechanistically, the FOA is positioned around the idea that neoantigens and neoepitopes may play a meaningful role in breaking immune tolerance and shaping autoimmune attack in type 1 diabetes. By funding detailed characterization of these targets and the immune responses they elicit, the program is aimed at generating knowledge that could ultimately support better diagnostics, improved stratification of risk, and more precise immune interventions. While the notice is labeled "Clinical Trial Optional," it is structured as an R01 research grant and allows (but does not require) clinical trial components when they are justified by the research plan, such as studies involving human samples, immune phenotyping in patient cohorts, or clinically anchored investigations that meet NIH definitions for clinical research.

From an administrative standpoint, this is an NIH grant (CFDA 93.847) under the health funding activity category. The original closing date listed is 2018-12-06, and the opportunity record shows a creation date of 2018-02-15. No award ceiling or expected number of awards is specified in the provided source data, which is sometimes the case for NIH FOAs where budgets depend on the scope and standard R01 constraints rather than a fixed cap stated in the summary record.

Eligibility is broad and inclusive, reflecting NIH norms and an explicit interest in supporting diverse institutions. Eligible applicants include a wide range of U.S. governmental entities (state, county, city/township, and special district governments), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and multiple types of nonprofit organizations (including both 501(c)(3) and non-501(c)(3) nonprofits, other than institutions of higher education). For-profit organizations (other than small businesses) and small businesses are also listed as eligible. In addition, the FOA highlights several categories of institutions and organizations often emphasized in federal outreach: Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and Indian/Native American Tribal Governments (other than federally recognized). It also notes that eligible applicants can include federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and even non-domestic (non-U.S.) entities (foreign organizations), indicating an openness to international participation where scientifically appropriate.

Overall, the opportunity is designed to push the type 1 diabetes field beyond the classic set of known autoantigens by promoting systematic discovery and rigorous immune characterization of novel and altered targets. The emphasis on both antibody and T cell responses, and on integrating new targets with established biomarkers like insulin, GAD65, IA-2, and ZnT8, reflects a practical, translational research direction: identifying immune signatures that better explain disease biology and could eventually inform prediction, monitoring, and more targeted therapies.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "The Characterization and Discovery of Novel Autoantigens and Epitopes in Type 1 Diabetes (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2018-02-15.
• Applicants must submit their applications by 2018-12-06. (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.

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