Development of HIV Broadly Neutralizing Antibody Susceptibility Assays (R61/R33 Clinical Trial Not Allowed) | RFA AI 22 022

Opportunity Information: Apply for RFA AI 22 022

The National Institutes of Health (NIH) funding opportunity RFA-AI-22-022, titled "Development of HIV Broadly Neutralizing Antibody Susceptibility Assays (R61/R33 Clinical Trial Not Allowed)," is a discretionary grant program in the health area (CFDA 93.855) aimed at accelerating the creation of laboratory assays that can measure how susceptible HIV is to broadly neutralizing antibodies (bNAbs). The core idea is to support the kind of work that is often considered too risky or too early-stage for conventional funding, but that could have high payoff if successful. These assays are intended for use in clinical laboratory settings, meaning applicants are expected to think beyond basic research prototypes and move toward approaches that could realistically be run, reproduced, and interpreted in labs that support clinical studies and patient-oriented research.

The program uses an R61/R33 phased innovation structure that is explicitly milestone-driven. In practice, that means projects are expected to begin with an early, high-risk development phase (R61) focused on designing new or improved susceptibility assays and generating convincing feasibility evidence. Applicants should show that the proposed method can work in principle, can produce interpretable outputs, and has a clear path to clinical utility. If the project meets predefined milestones, it can transition into the second phase (R33), which emphasizes more rigorous assay verification and late-stage validation. This later phase is where the method is expected to mature into something closer to a robust, reproducible, and clinically meaningful assay, with performance characteristics demonstrated in a way that supports broader adoption in clinical laboratories.

A major emphasis of the opportunity is innovation paired with practical readiness. The assays being developed should enable measurement of HIV susceptibility to bNAbs, which are increasingly important tools in HIV prevention and treatment research. Because HIV is genetically diverse and can escape immune pressure, being able to quantify or predict whether a given virus is sensitive or resistant to particular bNAbs can directly inform clinical research decisions, such as selecting antibodies for trials, interpreting outcomes, or monitoring resistance patterns. While the announcement does not dictate a single technical approach, the intent is to produce assay methods that move beyond exploratory laboratory techniques and toward standardized procedures that can be implemented consistently across clinical laboratory environments.

The opportunity strongly encourages collaborative and interdisciplinary teams, particularly partnerships that bridge academia and industry. This reflects the reality that translating an assay from a promising concept into a validated clinical-lab-ready method often requires combining expertise in virology, immunology, assay engineering, biostatistics, quality systems, clinical laboratory operations, and potentially product development and manufacturing considerations. Projects that incorporate these perspectives early are typically better positioned to define meaningful milestones, select appropriate sample sets and reference materials, and address practical constraints such as throughput, cost, robustness, and inter-lab reproducibility.

Eligibility is broad and includes many common applicant types: state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. On the international side, non-U.S. institutions are not eligible to apply directly, and non-U.S. components of U.S. organizations are not eligible; however, foreign components (as defined under the NIH Grants Policy Statement) are allowed, meaning a U.S.-based applicant can include certain foreign collaborations or activities when justified and compliant with NIH policy.

Administrative details included in the source information indicate the opportunity was created on March 10, 2022, with an original closing date of August 3, 2022. The funding mechanism is a grant, the category is discretionary, and the FOA title makes clear that clinical trials are not allowed under this announcement. In other words, the supported work should focus on assay development and validation activities rather than interventional clinical trial testing, even though the assays are intended to be usable in clinical laboratory contexts and supportive of clinical research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of HIV Broadly Neutralizing Antibody Susceptibility Assays (R61/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 2022-03-10.
• Applicants must submit their applications by 2022-08-03. (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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