Advancing Research Needed to Develop a Universal Influenza Vaccine (R01 Clinical Trial Not Allowed) | PA 18 859

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.

• 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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