New Therapeutic Strategies for Genital Herpes (R21/R33 Clinical Trial Not Allowed) | RFA AI 24 068

Opportunity Information: Apply for RFA AI 24 068

The National Institutes of Health (NIH) is soliciting grant applications under Funding Opportunity Number RFA-AI-24-068, titled "New Therapeutic Strategies for Genital Herpes (R21/R33 Clinical Trial Not Allowed)." The central goal of this opportunity is to push the field toward better treatments for genital herpes by supporting early, development-focused research that can lead to therapies that meaningfully suppress viral shedding and lesion formation and, importantly, help reduce transmission. In other words, NIH is looking for approaches that go beyond incremental improvements and aim for practical, measurable impact on how often the virus is active, how often symptoms occur, and how easily it spreads.

The scientific scope is intentionally broad and is meant to attract a wide range of technology and therapeutic concepts. Proposed projects can focus on creating new antivirals or improving existing antiviral strategies, developing monoclonal antibodies, advancing therapeutic vaccine concepts intended to help people already living with genital herpes, and exploring newer platform approaches such as gene editing technologies. The opportunity is geared toward moving promising ideas along a development pathway where feasibility, performance, and readiness can be demonstrated through well-defined experimental progress rather than open-ended discovery work.

A defining feature of this NOFO is its milestone-driven, two-phase (biphasic) award structure using the R21/R33 mechanism. The first phase (R21) generally supports early proof-of-concept and feasibility work, where applicants are expected to generate key data that de-risks the therapeutic approach. The second phase (R33) is designed to support more advanced development work that builds on successful R21 results, such as optimization, additional preclinical validation, and other steps that prepare an intervention for later-stage development. Transition from R21 to R33 is not automatic; it depends on whether the project meets pre-specified milestones. This structure signals that NIH expects applicants to propose clear, objective go/no-go criteria and a realistic development plan that can be evaluated at the phase transition.

The NOFO explicitly states "Clinical Trial Not Allowed," meaning applicants should not propose clinical trials under this mechanism. While the work may be translational and focused on product-enabling studies, it must stop short of conducting a clinical trial as defined by NIH policy. Applicants should therefore plan around preclinical and non-clinical development activities, or other research that advances a therapy toward human testing without actually initiating a clinical trial within this award.

In terms of administrative details, this is a discretionary grant opportunity under the health funding activity category, associated with CFDA number 93.855. The opportunity was created on October 15, 2024, and the original closing date is January 31, 2025. The funding instrument is a grant, and the sponsoring agency is NIH. The listing provides an "Award Ceiling" field but does not specify a dollar amount in the provided text, and the "Expected Awards" field is also not populated here, so applicants would need to consult the full announcement for budget limits, project period details, and the anticipated number of awards.

Eligibility is broad and includes many types of U.S.-based organizations and certain non-U.S. entities. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, and public housing authorities or Indian housing authorities. Academic eligibility spans public and state-controlled institutions of higher education as well as private institutions of higher education. Tribal entities are included, covering federally recognized Native American tribal governments and also Native American tribal organizations and tribal governments that are not federally recognized. The opportunity is also open to nonprofits (both with and without 501(c)(3) status, excluding institutions of higher education in those categories), for-profit organizations (other than small businesses), and small businesses. The NOFO also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). Taken together, this reflects an intent to draw in diverse institutional partners, including community-based groups and international teams where relevant expertise or capacity exists.

Overall, the opportunity is designed for teams that can propose a credible, milestone-oriented development plan for next-generation genital herpes therapeutics, with near-term deliverables that demonstrate whether a candidate approach is viable. Competitive applications will typically be those that define measurable endpoints aligned with the program goals (reducing shedding, lesions, and transmission potential), articulate a clear path from early feasibility to more advanced development, and present realistic milestones that justify progression from the R21 phase into the R33 phase.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "New Therapeutic Strategies for Genital Herpes (R21/R33 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 2024-10-15.
• Applicants must submit their applications by 2025-01-31. (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.

Apply for RFA AI 24 068

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: