Rational Design of Vaccines Against Hepatitis C Virus (U19 Clinical Trial Not Allowed) | RFA AI 20 019

Opportunity Information: Apply for RFA AI 20 019

The National Institutes of Health (NIH) funding opportunity announcement titled "Rational Design of Vaccines Against Hepatitis C Virus (U19 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA AI 20 019) supports multi-project, collaborative research programs aimed at creating better prophylactic vaccines for hepatitis C virus (HCV). The award mechanism is a cooperative agreement (U19), which typically means NIH staff will have substantial scientific involvement during the project period, often through milestones, coordinated planning, and ongoing programmatic input. The emphasis is on accelerating progress from basic discovery toward well-justified vaccine candidates that can move into preclinical development and, ultimately, clinical testing, while explicitly excluding clinical trials under this specific announcement.

The scientific goal is to enable "rational" vaccine design, meaning vaccine concepts should be driven by a clear mechanistic understanding of how protective immunity against HCV can be achieved. This includes advancing knowledge of the structural and immunological features that can produce broad protection across HCV diversity, a major obstacle for vaccine development because the virus shows extensive genetic variability and has evolved multiple ways to evade immune responses. Projects are expected to generate insights into the structural basis of broadly protective immune recognition (for example, defining antibody binding sites or T cell targets that are conserved and functionally important), and then use those insights to guide the design of improved immunogens and vaccine platforms.

A central expectation in this FOA is the identification and refinement of correlates of protection for HCV. Applicants are encouraged to leverage samples and data from existing human cohorts and prior vaccine studies to determine what immune signatures are associated with natural control, clearance, or protection from infection. This could include analyzing neutralizing antibody breadth and potency, mapping epitopes associated with protection, dissecting B cell lineages that produce broadly neutralizing responses, and characterizing T cell quality, specificity, and durability. The intent is to translate these findings into concrete design rules that inform the construction of next-generation vaccine candidates rather than relying on empirical trial-and-error approaches.

The program then expects candidate prophylactic vaccines to be assessed for immunogenicity and efficacy in appropriate animal models. While the FOA text does not list specific models, the general thrust is that applicants should use models that can meaningfully evaluate the immune responses of interest and provide evidence supporting progression toward preclinical development. The overall pipeline envisioned is: generate structural and immunologic knowledge, apply it to design vaccine candidates, test and compare candidates in relevant preclinical settings, and select the strongest candidates for subsequent development stages (with the understanding that actual clinical trials are not supported under this announcement).

In terms of eligibility, the FOA is broadly accessible across government, academic, nonprofit, and industry sectors. Eligible applicants include state, county, city/township, and 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; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, 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, reflecting a strong interest in inclusive participation and broad collaboration.

Administratively, the opportunity falls under the health research category with CFDA number 93.855 and was created on 2020-02-24, with an original closing date of 2020-06-15. The FOA does not specify an award ceiling or expected number of awards in the provided source text, but the U19 structure generally implies support for a coordinated set of interrelated projects and cores rather than a single standalone research aim. In practical terms, competitive applications would typically be expected to show an integrated plan that connects discovery, design, and comparative evaluation of vaccine candidates, with clear decision points for down-selection based on immune response quality and evidence of potential protective benefit.

Overall, this FOA is designed to push the field toward HCV vaccines that are engineered based on clear protective principles: understanding what protective human immunity looks like, understanding the viral structures and conserved targets that can elicit that immunity, and building vaccine candidates that reliably induce those responses in preclinical testing. The end product NIH is aiming for is not just new data, but a set of validated vaccine design strategies and prioritized candidates ready to advance into the next stages of development outside the scope of this particular non-clinical-trial funding mechanism.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Rational Design of Vaccines Against Hepatitis C Virus (U19 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 2020-02-24.
• Applicants must submit their applications by 2020-06-15. (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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