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.Apply for RFA DK 17 031
- 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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Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "The Characterization and Discovery of Novel Autoantigens and Epitopes in Type 1 Diabetes (R01 Clinical Trial Optional)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-DK-17-031.
Which agency is offering this grant?
This is a National Institutes of Health (NIH) discretionary grant opportunity.
What type of grant mechanism is this?
It is structured as an R01 research grant.
What is the central scientific goal of the FOA?
The central aim is to support original, hypothesis-driven studies that identify and characterize previously unrecognized autoantigens and epitopes involved in type 1 diabetes, with a strong emphasis on neoantigens and neoepitopes that may contribute to disease initiation and progression.
What does the FOA mean by "neoantigens" and "neoepitopes" in type 1 diabetes?
In this FOA, neoantigens and neoepitopes refer to altered forms of self-proteins that may appear foreign to the immune system due to processes such as post-translational modification, abnormal protein processing, hybrid peptide formation, or other changes that create novel immune targets.
What kinds of research activities does the FOA encourage?
The FOA encourages work that goes beyond identifying new candidate targets by also characterizing the immune responses they provoke. This can include mapping epitope regions, determining HLA restriction, identifying which immune cells recognize specific neoepitopes, and measuring the magnitude and phenotype of immune responses.
Does the FOA emphasize any particular immune response types?
Yes. The FOA emphasizes connecting antigen discovery to immune function, including both humoral immunity (autoantibodies) and cell-mediated immunity (T cell responses).
How should applicants connect new antigen/epitope findings to disease stages?
The FOA encourages linking immune signatures to clinically relevant stages such as pre-symptomatic autoimmunity, disease onset, or established type 1 diabetes.
Does the FOA expect integration with existing, well-known type 1 diabetes antigens?
Yes. Projects are expected to integrate new findings with established antigens and epitopes commonly used in type 1 diabetes research and risk prediction.
Which established autoantibody targets are explicitly referenced?
The FOA explicitly references insulin, GAD65, IA-2, and ZnT8 as well-known autoantibody targets to be considered when situating novel targets within the current framework.
What are examples of how applicants might integrate novel targets with established markers?
Examples described or implied in the FOA include comparing novel antibody or T cell reactivities to known reactivities, testing whether neoepitope responses precede or follow the appearance of classic autoantibodies, and evaluating whether novel targets help explain individuals or cases not well captured by established markers.
Why is the FOA focused on neoantigens/neoepitopes mechanistically?
The FOA is positioned around the idea that neoantigens and neoepitopes may help break immune tolerance and shape autoimmune attack in type 1 diabetes. Detailed characterization is intended to clarify the etiology and pathophysiology of beta cell damage and loss.
What longer-term impact is NIH aiming for through this FOA?
The program aims to generate knowledge that could ultimately support better diagnostics, improved stratification of risk, and more precise immune interventions in type 1 diabetes.
Is a clinical trial required?
No. The FOA is labeled "Clinical Trial Optional," meaning clinical trial components are allowed but not required.
What does "Clinical Trial Optional" allow in practice?
It allows (when justified by the research plan) clinical or clinically anchored components consistent with NIH definitions, such as studies involving human samples, immune phenotyping in patient cohorts, or other clinical research elements.
Is the FOA limited only to human studies?
The FOA highlights examples involving human samples and patient cohorts in the context of optional clinical research components, but it is broadly framed around antigen discovery and immune characterization in type 1 diabetes.
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.847.
What is the funding activity category?
The funding activity category is listed as health.
When was the opportunity record created?
The opportunity record shows a creation date of 2018-02-15.
What was the original closing date?
The original closing date listed is 2018-12-06.
Is an award ceiling specified?
No award ceiling is specified in the provided information.
Is the expected number of awards specified?
No. The provided information indicates that the expected number of awards is not specified in the source data.
Who is eligible to apply for this NIH FOA?
Eligibility is broad. Eligible applicants include many U.S. governmental entities, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including 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 state and local government entities eligible?
Yes. The eligible applicant types listed include state governments, county governments, city or township governments, and special district governments.
Are colleges and universities eligible?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are nonprofit organizations eligible?
Yes. The FOA lists nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (other than institutions of higher education) as eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed as eligible.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA highlights 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); and Tribally Controlled Colleges and Universities (TCCUs).
Are tribal governments eligible?
Yes. The FOA notes Indian/Native American Tribal Governments (other than federally recognized) among the highlighted eligible categories.
Can federal agencies apply?
Yes. Federal agencies are listed among eligible applicants.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly mentioned as eligible.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the list of eligible applicants.
Are regional organizations eligible?
Yes. Regional organizations are mentioned as eligible.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA indicates that non-domestic (non-U.S.) entities (foreign organizations) are eligible, suggesting openness to international participation where scientifically appropriate.
What is the main scientific theme that distinguishes this FOA from classic autoantigen work?
The distinguishing theme is a push beyond the classic set of known autoantigens, with an emphasis on systematic discovery and rigorous immune characterization of novel and altered targets (neoantigens/neoepitopes) and integrating them with established biomarkers and immune monitoring approaches.
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