Opportunity Information: Apply for PA 18 859
The grant opportunity "Advancing Research Needed to Develop a Universal Influenza Vaccine (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number PA 18 859) is a discretionary NIH funding announcement run through the National Institute of Allergy and Infectious Diseases (NIAID). It supports research aimed at moving the field closer to a universal influenza vaccine, meaning a vaccine that can provide durable, broad protection across many influenza strains rather than needing frequent reformulation to match circulating seasonal variants. The announcement is focused on fundamental and translational research that strengthens the scientific foundation for universal vaccine development, but it explicitly does not allow clinical trials under this mechanism.
The overall purpose is tightly aligned with NIAIDs long-term mission to enable a next-generation influenza vaccine strategy. Projects are expected to contribute to one or more of three major research thrusts. First, the FOA encourages studies that improve understanding of influenza transmission, natural history, and pathogenesis. This can include work that clarifies how influenza spreads between hosts, what factors shape infection dynamics, what determines disease severity, and how infection progresses over time in different populations or settings. Second, it supports research to characterize influenza immunity and identify correlates of immune protection. In practice, this means defining which immune responses actually predict protection (for example, specific antibody functions, breadth of neutralization, mucosal immunity, T cell responses, or other immune signatures) and determining how these responses vary by virus subtype, prior exposure history, age, or other host factors. Third, the FOA prioritizes research that enables rational design of universal influenza vaccines, which generally refers to using mechanistic knowledge of the virus and immune response to guide antigen selection, immunogen design, delivery platforms, and immunization regimens, rather than relying mainly on empirical approaches.
The funding mechanism used is the NIH R01, which is typically intended for more mature projects that can support a larger, multi-year research plan. The FOA notes a companion opportunity that uses the R21 mechanism, which is more geared toward exploratory or early-stage work, especially higher-risk projects that may not yet have extensive preliminary data or that leverage existing datasets in a novel way. In contrast, this R01 opportunity is positioned for applicants who already have preliminary findings and want to pursue longer-term, more comprehensive studies to advance universal influenza vaccine-enabling science. While there is room for ambitious work, the framing suggests the R01 route is best suited for proposals that can demonstrate feasibility and a clear trajectory toward impactful outcomes.
Eligibility is broad and includes many types of institutions and organizations. Standard eligible applicants include state, county, 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; small businesses; and other entities. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This broad eligibility reflects an intent to pull in expertise from a wide range of research environments, including domestic and international groups with strong influenza science capabilities.
Administratively, this is a grant in the NIH health funding category and is associated with CFDA number 93.855. The opportunity was created on 2018-07-18, and the listed original closing date in the provided record is 2021-09-07. The summary data provided does not specify an award ceiling or the expected number of awards, which typically means applicants would need to consult the full FOA text and NIH budget guidance for any institute-specific caps, typical award sizes, and budget justification expectations. The key practical constraint emphasized in the title is that clinical trials are not allowed, so proposed work should be non-clinical trial research, such as preclinical studies, immunological and virological investigations, model development, antigen and vaccine design research, and related analyses that do not meet NIH definitions of a clinical trial.Apply for PA 18 859
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Research Needed to Develop a Universal Influenza Vaccine (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 2018-07-18.
- Applicants must submit their applications by 2021-09-07. (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 name of this grant opportunity?
The opportunity is titled "Advancing Research Needed to Develop a Universal Influenza Vaccine (R01 Clinical Trial Not Allowed)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number listed is PA 18 859.
Which agency and institute are running this opportunity?
This is an NIH discretionary funding announcement administered through the National Institute of Allergy and Infectious Diseases (NIAID).
What is the main goal of the program?
The goal is to support research that moves the field closer to a universal influenza vaccine, meaning a vaccine intended to provide durable, broad protection across many influenza strains rather than requiring frequent reformulation to match seasonal circulating variants.
What type of research does the FOA support?
The FOA supports fundamental and translational research that strengthens the scientific foundation for developing universal influenza vaccines.
Are clinical trials allowed under this R01 opportunity?
No. Clinical trials are explicitly not allowed under this mechanism, as indicated in the title "Clinical Trial Not Allowed."
If clinical trials are not allowed, what kinds of projects fit this FOA?
Projects should be non-clinical trial research such as preclinical studies, immunological and virological investigations, model development, antigen and vaccine design research, and related analyses that do not meet NIH definitions of a clinical trial.
What are the major research thrusts emphasized by the FOA?
Projects are expected to contribute to one or more of three thrusts: (1) improving understanding of influenza transmission, natural history, and pathogenesis; (2) characterizing influenza immunity and identifying correlates of immune protection; and (3) enabling rational design of universal influenza vaccines.
What does the FOA mean by research on influenza transmission, natural history, and pathogenesis?
This includes studies that clarify how influenza spreads between hosts, factors that shape infection dynamics, what determines disease severity, and how infection progresses over time in different populations or settings.
What does "characterize influenza immunity and identify correlates of immune protection" mean in practice?
It refers to defining which immune responses predict protection (for example, specific antibody functions, breadth of neutralization, mucosal immunity, T cell responses, or other immune signatures) and determining how these responses vary by virus subtype, prior exposure history, age, or other host factors.
What does "rational design of universal influenza vaccines" refer to?
It generally refers to using mechanistic knowledge of the virus and immune responses to guide antigen selection, immunogen design, delivery platforms, and immunization regimens, rather than relying mainly on empirical approaches.
What funding mechanism is used for this opportunity?
The mechanism is the NIH R01.
What does it imply that this is an R01 opportunity?
R01s are typically intended for more mature projects that can support a larger, multi-year research plan. In the context provided, this FOA is positioned for applicants who already have preliminary findings and want to pursue longer-term, more comprehensive studies.
Is there a related or companion opportunity mentioned?
Yes. The FOA notes a companion opportunity using the R21 mechanism, which is more geared toward exploratory or early-stage work and may be appropriate for higher-risk projects with less preliminary data or projects leveraging existing datasets in a novel way.
How is this R01 positioned relative to the R21 companion opportunity?
Based on the description, the R01 is better suited for proposals that can demonstrate feasibility with preliminary findings and present a clear trajectory toward impactful outcomes, while the R21 is oriented toward exploratory or early-stage efforts.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include many types of U.S. government entities, educational institutions, nonprofits, for-profits (including small businesses and other than small businesses), tribal entities, public housing authorities/Indian housing authorities, and other entities.
Are state and local governments eligible?
Yes. The listed eligible applicants include state governments, county governments, city or township governments, and special district governments.
Are schools and universities eligible?
Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are listed as eligible applicants.
Are nonprofits eligible, including those without 501(c)(3) status?
Yes. Nonprofits with or without 501(c)(3) status are listed as eligible, excluding higher education institutions in those nonprofit categories.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are eligible, and small businesses are also eligible.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are highlighted among additional eligible applicant categories.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, and TCCUs.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed among eligible applicant categories.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are specifically listed as eligible.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.855.
What funding category is this listed under?
It is described as a grant in the NIH health funding category.
When was the opportunity created?
The record states the opportunity was created on 2018-07-18.
What is the closing date shown in the provided record?
The provided record lists an original closing date of 2021-09-07.
Does the provided summary specify an award ceiling or number of awards?
No. The summary data provided does not specify an award ceiling or the expected number of awards.
If the summary does not list award size or number of awards, where would applicants typically look?
The summary indicates applicants would typically need to consult the full FOA text and NIH budget guidance for institute-specific caps, typical award sizes, and budget justification expectations.
What is the overarching program intent from NIAID described here?
The purpose is described as tightly aligned with NIAID's long-term mission to enable a next-generation influenza vaccine strategy.
Is this opportunity focused on seasonal strain-matching vaccines?
The emphasis is on universal influenza vaccine-enabling science aimed at durable, broad protection across many strains, rather than frequent reformulation to match circulating seasonal variants.
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| Funding Opportunity |
|---|
| Advancing Research Needed to Develop a Universal Influenza Vaccine (R21 Clinical Trial Not Allowed) Apply for PA 18 858 Funding Number: PA 18 858 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research (K01 Independent Clinical Trial Required) Apply for RFA HL 19 025 Funding Number: RFA HL 19 025 Agency: National Institutes of Health Category: Health Funding Amount: $150,000 |
| NEI Vision Research Epidemiology Grant (UG1 Clinical Trial Not Allowed) Apply for PAR 18 864 Funding Number: PAR 18 864 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Immune Response to Arthropod Blood Feeding (R21 Clinical Trial Not Allowed) Apply for PAR 18 860 Funding Number: PAR 18 860 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Mentored Career Development Award to Promote Faculty Diversity in Biomedical Research (K01 Independent Clinical Trial Not Allowed) Apply for RFA HL 19 026 Funding Number: RFA HL 19 026 Agency: National Institutes of Health Category: Health Funding Amount: $150,000 |
| Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Musculoskeletal Diseases (X02 Clinical Trial Not Allowed) Apply for PAR 18 865 Funding Number: PAR 18 865 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed) Apply for RFA AR 19 013 Funding Number: RFA AR 19 013 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Pilot Projects Investigating Understudied G Protein-Coupled Receptors, Ion Channels, and Protein Kinases (R03 Clinical Trial Not Allowed) Apply for RFA RM 18 021 Funding Number: RFA RM 18 021 Agency: National Institutes of Health Category: Health Funding Amount: $100,000 |
| Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02 Clinical Trial Not Allowed) Apply for PAR 18 866 Funding Number: PAR 18 866 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Genome Sequencing Center for the Gabriella Miller Kids First Pediatric Research Program (U24 Clinical Trial Not Allowed) Apply for RFA RM 18 030 Funding Number: RFA RM 18 030 Agency: National Institutes of Health Category: Health Funding Amount: $8,000,000 |
| Novel Approaches for Relating Genetic Variation to Function and Disease (R21 Clinical Trial Not Allowed) Apply for PA 18 867 Funding Number: PA 18 867 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Novel Approaches for Relating Genetic Variation to Function and Disease (R01 Clinical Trial Not Allowed) Apply for PA 18 868 Funding Number: PA 18 868 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Research Innovations for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (R61/R33 Clinical Trial Not Allowed) Apply for RFA AR 19 012 Funding Number: RFA AR 19 012 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Research to Advance Vaccine Safety (R01 Clinical Trial Not Allowed) Apply for PA 18 873 Funding Number: PA 18 873 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| HIV Drug Resistance: Genotype-Phenotype-Outcome Correlations (R01 Clinical Trial Not Allowed) Apply for RFA AI 18 029 Funding Number: RFA AI 18 029 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Research to Advance Vaccine Safety (R21 Clinical Trial Not Allowed) Apply for PA 18 872 Funding Number: PA 18 872 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Biologic Factors Underlying Dental, Oral, and Craniofacial Health Disparities (R21 - Clinical Trial Not Allowed) Apply for PA 18 874 Funding Number: PA 18 874 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Innovative Technologies to Deliver Genome Editing Machinery to Disease-relevant Cells and Tissues (UG3/UH3 Clinical Trial Not Allowed) Apply for RFA RM 18 023 Funding Number: RFA RM 18 023 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Biologic Factors Underlying Dental, Oral, and Craniofacial Health Disparities (R01 - Clinical Trial Not Allowed) Apply for PAR 18 875 Funding Number: PAR 18 875 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Innovative Technologies to Non-Invasively Monitor Genome Edited Cells In Vivo (UH2/UH3 Clinical Trial Not Allowed) Apply for RFA RM 18 025 Funding Number: RFA RM 18 025 Agency: National Institutes of Health Category: Health Funding Amount: $150,000 |
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