Next-Generation Biologics for Sustained HIV Remission (R01 Clinical Trial Not Allowed) | RFA AI 18 017

Opportunity Information: Apply for RFA AI 18 017

Next-Generation Biologics for Sustained HIV Remission (R01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity that supports research aimed at creating and advancing new biologic approaches intended to achieve sustained HIV remission. The emphasis is on research and early-stage development of biologics that could help people living with HIV maintain long-term control of the virus without continuous antiretroviral therapy, which is often described as durable remission. This FOA is positioned as a preclinical and translational development effort rather than a clinical testing mechanism, which is reinforced by the "Clinical Trial Not Allowed" designation.

The opportunity is offered as a discretionary grant using the NIH R01 mechanism, which is commonly used for hypothesis-driven and developmental biomedical research projects with clearly defined aims. The Funding Opportunity Number is RFA-AI-18-017, and it falls under the NIH health research activity category. It is tied to CFDA numbers 93.242 and 93.855, indicating alignment with NIH program areas that include infectious diseases and immunology-related research portfolios.

The core purpose of the FOA is to stimulate research that pushes beyond existing strategies and invests in next-generation biologics. While the announcement text provided is brief, the framing signals an interest in innovative biologic modalities and platforms that can plausibly move toward sustained remission, such as engineered antibodies, immune-based biologics, long-acting biologic agents, or other advanced biologic constructs designed to suppress or control HIV through immune mechanisms or targeted viral control strategies. The phrase "research on and early development" suggests that applicants are expected to generate convincing data packages that could support downstream advancement, for example by establishing proof-of-concept efficacy, defining mechanisms of action, optimizing candidate biologics, and addressing key development hurdles like potency, breadth, durability, delivery, manufacturability considerations, and preclinical safety signals. Because clinical trials are not allowed, the work would generally stop short of interventional studies in humans, focusing instead on discovery, optimization, and preclinical validation steps.

A wide range of organizations are eligible to apply. Standard eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; and federally recognized Native American tribal governments. Eligibility also extends to public housing authorities and Indian housing authorities, as well as tribal organizations that are not federally recognized as governments. Both nonprofit organizations (with and without 501(c)(3) status) may apply, and the FOA also allows for-profit entities (other than small businesses) and small businesses. In addition, the announcement explicitly highlights several other eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and 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; eligible federal agencies; U.S. territories or possessions; and non-U.S. entities (foreign organizations) as well as regional organizations. This breadth of eligibility is consistent with NIH efforts to attract diverse scientific teams and institutional participation, including organizations that may contribute unique community, immunology, virology, biologics engineering, or implementation-relevant expertise, even when the funded work itself is not a clinical trial.

Key administrative details include an original closing date of July 27, 2018, and a creation date of April 11, 2018, which indicates this specific FOA was tied to a defined submission window during that period. The award ceiling is listed at $500,000, which typically signals a cap on direct costs per year or on some other budgetary basis depending on the FOA terms, but the provided text only includes the ceiling figure itself. The expected number of awards is not specified in the source data excerpt, which means applicants would need to consult the full FOA for any information about anticipated funding level, number of awards, project period expectations, and any budget format requirements.

In practical terms, a competitive application under this FOA would likely describe a clear biologic candidate or biologic platform, explain why it is meaningfully "next-generation" relative to existing HIV biologics, and outline a rigorous plan to generate the kinds of preclinical evidence needed to justify further advancement. That usually includes well-supported aims, appropriate model systems, strong assays for viral control and immune function, and attention to development realities like dosing durability, resistance considerations, and scalable production pathways. Since clinical trials are not allowed, the application would need to be careful about human subject research boundaries and present a program that is clearly focused on non-clinical or preclinical milestones that move the field closer to sustained HIV remission without proposing a clinical intervention study.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Next-Generation Biologics for Sustained HIV Remission (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): 93.242, 93.855.
• This funding opportunity was created on 2018-04-11.
• Applicants must submit their applications by 2018-07-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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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