Consortium for Innovative HIV/AIDS Vaccine and Cure Research (UM1 Clinical Trial Not Allowed) | RFA AI 21 039

Opportunity Information: Apply for RFA AI 21 039

The National Institutes of Health (NIH) funding opportunity RFA-AI-21-039, titled "Consortium for Innovative HIV/AIDS Vaccine and Cure Research (UM1 Clinical Trial Not Allowed)," is a discretionary health research program that uses a cooperative agreement mechanism (UM1). The central aim is to build and support multi-institution consortia that can work as an integrated team to push forward research that directly informs two major goals in the HIV field: preventing infection through effective vaccination and advancing strategies that contribute to an HIV cure. Because this is a cooperative agreement, NIH is expected to have substantial involvement in guiding and coordinating the program’s overall direction, milestones, and collaborative structure rather than functioning as a purely hands-off funder.

Scientifically, the FOA is organized around two linked focus areas. First, it prioritizes identifying the correlates of protection and the underlying mechanisms by which preventive HIV/AIDS vaccines work. In practical terms, this means the consortium is expected to study what immune responses (and which biological pathways) are responsible for blocking infection or preventing systemic spread after exposure. The second focus area is the use of vaccines or other immune-based approaches to advance cure research. Here, the emphasis is on leveraging immunologic tools, potentially including therapeutic vaccines or other immune modalities, as part of strategies designed to control or eliminate HIV reservoirs, which are the persistent viral hiding places that remain even when standard antiretroviral therapy suppresses virus in the blood.

A defining feature of this opportunity is its heavy emphasis on preclinical research in nonhuman primate (NHP) models, particularly studies using SIV or SHIV infection systems. The FOA supports work that examines how vaccines that show efficacy in NHPs actually provide protection, such as blocking initial acquisition or preventing the establishment of systemic infection after exposure. It also supports incorporating vaccines or other immune interventions into cure-oriented strategies in SIV- or SHIV-infected NHPs, with goals such as reducing or eliminating viral reservoirs or achieving durable "elite control" of viral replication without continuous therapy. The intent is that the mechanistic and translational insights gained in NHPs will be directly applicable to improving HIV vaccine concepts and cure strategies, strengthening the evidence base needed to justify and design future human studies.

Even though the long-term trajectory is to inform eventual human evaluation, this specific UM1 notice is "Clinical Trial Not Allowed," meaning applicants should not propose human clinical trials under this award. The work is expected to stay in the preclinical and mechanistic space, with an eye toward generating the kind of rigorous data that can support later-stage clinical testing under different mechanisms or future announcements.

Eligibility is broad across many U.S.-based organization types. 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; federally recognized tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education when specified); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly calls out a range of additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, the announcement places clear limits on non-U.S. participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement are allowed, which typically means a U.S. applicant can include certain well-justified international elements or collaborations within the project, as long as they meet NIH’s policy requirements and are appropriately structured.

Administratively, the opportunity is listed under CFDA 93.855, with an original closing date of August 4, 2021, and a creation date of May 7, 2021. The award ceiling and expected number of awards are not specified in the provided source data. Overall, the program is designed to support coordinated, consortium-based, preclinical research that connects vaccine immunology and cure-oriented immune strategies in NHP models, producing actionable insights that can accelerate the design and refinement of future HIV vaccines and cure approaches headed toward eventual clinical evaluation.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Consortium for Innovative HIV/AIDS Vaccine and Cure Research (UM1 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 2021-05-07.
• Applicants must submit their applications by 2021-08-04. (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 21 039

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