Opportunity Information: Apply for RFA AI 23 054
The National Institutes of Health (NIH) is offering an R01 grant opportunity titled "Fc-Dependent Mechanisms of Antibody-Mediated Killing (R01 Clinical Trial Not Allowed)" under Funding Opportunity Number RFA-AI-23-054 (CFDA 93.855). This is a discretionary health research grant focused on basic, non-clinical trial research aimed at clarifying how antibodies eliminate infected cells through Fc-dependent effector functions. In practical terms, the program is centered on what antibodies can do beyond neutralization, especially in situations where neutralizing antibodies are weak, hard to induce, or simply not enough to clear an infection.
The scientific emphasis is on Fc-mediated mechanisms of antibody function, particularly antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP). ADCC generally refers to immune cells recognizing antibody-coated target cells and killing them, while ADCP refers to immune cells engulfing and clearing antibody-tagged targets. The NOFO is looking for studies that dig into the underlying biology of these processes: what molecular interactions matter, which immune cell types drive the effect, how Fc receptors and downstream signaling shape outcomes, and what antibody features (such as isotype/subclass, Fc glycosylation patterns, affinity/avidity, epitope specificity, and geometry of binding) influence killing or clearance.
A key deliverable NIH is signaling is the generation of foundational data sets and practical tools that help predict Fc-mediated killing activity by antibodies. That includes work that can lead to better assays, reference standards, or analytic frameworks that make Fc-effector performance more measurable and more comparable across studies. The larger goal is to make it easier to identify, design, and optimize antibodies or immune responses that reliably drive Fc-dependent clearance, thereby accelerating therapeutic monoclonal antibody development and informing vaccine or vaccine-adjuvant strategies that intentionally elicit these kinds of functional antibody responses.
This opportunity is explicitly "Clinical Trial Not Allowed," meaning the supported work should remain in the basic research domain (for example, mechanistic studies, preclinical models, in vitro systems, and method development) rather than testing interventions in human participants as a clinical trial. The intent is to strengthen the mechanistic foundation so later-stage translational efforts can be guided by clearer, predictive understanding of Fc-driven effector functions.
The applicant pool is broad. Eligible applicants include a wide range of U.S. public entities (state, county, city/township governments, special districts, independent school districts, and public housing authorities), tribal governments and tribal organizations, and higher education institutions (public/state-controlled and private). Nonprofits with or without 501(c)(3) status are eligible, as are for-profit organizations (other than small businesses) and small businesses. The NOFO also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations) as well as regional organizations.
Key administrative details provided include an original application closing date of 2024-01-26, with an award ceiling listed as $300,000. The opportunity was created on 2023-09-26. Overall, the NOFO is positioning Fc-effector biology as a critical piece of the immunology toolkit for infectious disease control, with an emphasis on generating broadly useful mechanistic insights and predictive capabilities that can be carried forward into antibody therapeutics and next-generation vaccine design.Apply for RFA AI 23 054
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Fc-Dependent Mechanisms of Antibody-Mediated Killing (R01 Clinical Trial Not Allowed)" 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 2023-09-26.
- Applicants must submit their applications by 2024-01-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- 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)
1) What is this NIH funding opportunity?
This opportunity is an NIH R01 grant titled "Fc-Dependent Mechanisms of Antibody-Mediated Killing (R01 Clinical Trial Not Allowed)" under Funding Opportunity Number RFA-AI-23-054 (CFDA 93.855). It supports discretionary health research focused on basic, non-clinical trial studies that clarify how antibodies eliminate infected cells through Fc-dependent effector functions.
2) What is the main scientific goal of the program?
The program aims to strengthen the mechanistic foundation for how antibodies drive Fc-dependent killing or clearance of infected cells. NIH is emphasizing antibody functions beyond neutralization, particularly in settings where neutralizing antibodies are weak, difficult to induce, or not sufficient to clear infection.
3) What does "Fc-dependent mechanisms" mean in this context?
It refers to antibody activities that rely on the Fc region of an antibody (the portion that interacts with Fc receptors on immune cells). These Fc interactions can trigger immune effector functions that help kill or remove infected cells that have been tagged by antibodies.
4) Which Fc-mediated effector functions are specifically highlighted?
The opportunity specifically highlights:
- Antibody-dependent cellular cytotoxicity (ADCC): immune cells recognize antibody-coated target cells and kill them.
- Antibody-dependent cell-mediated phagocytosis (ADCP): immune cells engulf and clear antibody-tagged targets.
5) What kinds of research questions is NIH looking for?
NIH is looking for studies that dig into the underlying biology of Fc-mediated processes, such as:
- Which molecular interactions matter for Fc-mediated killing or clearance
- Which immune cell types drive ADCC and/or ADCP outcomes
- How Fc receptors and downstream signaling shape functional outcomes
- Which antibody features influence killing/clearance performance
6) What antibody features are called out as important to study?
The NOFO notes several antibody characteristics that may influence Fc-effector function, including:
- Isotype/subclass
- Fc glycosylation patterns
- Affinity and avidity
- Epitope specificity
- Geometry of binding
7) What types of deliverables does NIH want from funded projects?
A key deliverable is the generation of foundational data sets and practical tools that help predict Fc-mediated killing activity. This includes work that could lead to improved assays, reference standards, or analytic frameworks that make Fc-effector performance more measurable and more comparable across studies.
8) Is the opportunity focused on therapeutic antibodies, vaccines, or both?
Based on the description provided, the program is designed to produce mechanistic and predictive knowledge that can accelerate therapeutic monoclonal antibody development and inform vaccine or vaccine-adjuvant strategies that intentionally elicit functional Fc-dependent antibody responses.
9) Are clinical trials allowed under this funding opportunity?
No. The opportunity is explicitly labeled "Clinical Trial Not Allowed," meaning the supported work should remain in the basic research domain rather than testing interventions in human participants as a clinical trial.
10) What types of studies fit the "Clinical Trial Not Allowed" scope described here?
Examples mentioned or implied include mechanistic studies, preclinical models, in vitro systems, and method development focused on Fc-effector biology and prediction, rather than intervention testing in human participants.
11) Why is NIH emphasizing non-neutralizing antibody functions?
The program is centered on what antibodies can do beyond neutralization because neutralizing antibodies can be weak, hard to induce, or insufficient on their own to clear an infection. Fc-mediated effector functions may provide additional or complementary mechanisms for eliminating infected cells.
12) How does this opportunity aim to improve comparability across studies?
NIH signals interest in outputs like better assays, reference standards, and analytic frameworks. These resources are intended to make Fc-effector activity more measurable and more comparable across different labs and studies.
13) What is the broader impact NIH is aiming for?
The larger goal is to make it easier to identify, design, and optimize antibodies or immune responses that reliably drive Fc-dependent clearance. This is positioned as a way to accelerate antibody therapeutic development and guide next-generation vaccine design using clearer, predictive understanding of Fc-driven effector functions.
14) Who is eligible to apply?
The eligible applicant pool is broad and includes:
- U.S. public entities (state, county, city/township governments, special districts, independent school districts, and public housing authorities)
- Tribal governments and tribal organizations
- Higher education institutions (public/state-controlled and private)
- Nonprofits with or without 501(c)(3) status
- For-profit organizations (other than small businesses) and small businesses
- Eligible federal agencies
- U.S. territories or possessions
- Non-U.S. entities (foreign organizations)
- Regional organizations
15) Are minority-serving institutions and community-based organizations explicitly included?
Yes. The NOFO explicitly calls out categories including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and faith-based or community-based organizations as eligible applicants.
16) What is the Funding Opportunity Number and CFDA listing?
The Funding Opportunity Number is RFA-AI-23-054 and the CFDA number listed is 93.855.
17) What is the application deadline provided?
The original application closing date provided is 2024-01-26.
18) What is the maximum award amount mentioned?
An award ceiling of $300,000 is listed in the information provided.
19) When was this opportunity created?
The opportunity was created on 2023-09-26.
20) What type of grant mechanism is being used?
This is an NIH R01 mechanism, described here as a discretionary health research grant supporting basic, non-clinical trial research on Fc-dependent antibody-mediated killing mechanisms.
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