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.Apply for RFA AI 21 039
- 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.
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Frequently Asked Questions (FAQs)
What is the official funding opportunity and title?
The opportunity is a National Institutes of Health (NIH) funding opportunity announcement (FOA) with number RFA-AI-21-039, titled "Consortium for Innovative HIV/AIDS Vaccine and Cure Research (UM1 Clinical Trial Not Allowed)."
What type of program is this?
This is a discretionary health research program that uses a cooperative agreement funding mechanism (UM1).
What does it mean that this is a cooperative agreement (UM1)?
Because it is a cooperative agreement, NIH is expected to have substantial involvement in guiding and coordinating the program. That includes shaping overall direction, milestones, and how the consortium collaborates, rather than serving only as a hands-off funder.
What is the main goal of this opportunity?
The central goal is to build and support multi-institution consortia that work as an integrated team to advance research that directly informs two major HIV field goals: preventing HIV infection through effective vaccination and advancing strategies that contribute to an HIV cure.
How is the science organized in this FOA?
The FOA is organized around two linked focus areas: (1) identifying correlates of protection and mechanisms of preventive HIV/AIDS vaccines, and (2) using vaccines or other immune-based approaches to advance HIV cure research.
What does "correlates of protection" mean in the context of this FOA?
In this FOA, correlates of protection refers to identifying which immune responses (and which biological pathways) are responsible for blocking infection or preventing systemic spread after exposure in preventive vaccine settings.
What kinds of questions are expected under the preventive vaccine focus area?
The consortium is expected to study how preventive HIV/AIDS vaccines work mechanistically, including what immune responses and pathways are associated with protection against acquisition or with preventing systemic infection after exposure.
What is the cure-focused part of the FOA aiming to do?
The cure-focused area emphasizes using vaccines or other immune-based approaches as part of strategies designed to control or eliminate HIV reservoirs, the persistent viral hiding places that remain even when antiretroviral therapy suppresses virus in the blood.
What role do vaccines play in the cure research described here?
The FOA specifically highlights leveraging immunologic tools, potentially including therapeutic vaccines or other immune modalities, in strategies intended to reduce or eliminate viral reservoirs or to achieve durable control of viral replication without continuous therapy.
Is this opportunity mainly clinical or preclinical?
It is heavily oriented toward preclinical and mechanistic research, with a defining emphasis on nonhuman primate (NHP) models.
Are human clinical trials allowed under this award?
No. The FOA is explicitly labeled "Clinical Trial Not Allowed," meaning applicants should not propose human clinical trials under this UM1 award.
If clinical trials are not allowed, how does the work relate to future human studies?
The intent is that mechanistic and translational insights from preclinical work (especially in NHP models) will generate rigorous evidence that can justify and help design future human studies under other mechanisms or future announcements.
What animal model focus does the FOA emphasize?
The FOA places heavy emphasis on preclinical research in nonhuman primate (NHP) models, particularly using SIV or SHIV infection systems.
What kinds of NHP vaccine efficacy questions are supported?
Supported work includes examining how vaccines that show efficacy in NHPs actually provide protection, such as blocking initial acquisition or preventing the establishment of systemic infection after exposure.
What kinds of NHP cure-strategy questions are supported?
The FOA 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.
What is meant by "elite control" in the FOA description?
In the context provided, "elite control" refers to durable control of viral replication without continuous therapy.
What is the expected structure of the research effort?
The FOA is designed to support coordinated, consortium-based, multi-institution research that operates as an integrated team.
What kinds of organizations are eligible to apply?
Eligibility is broad across many U.S.-based organization types, including: 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 (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.
Are specific institution categories explicitly mentioned as eligible?
Yes. The FOA explicitly calls out additional eligible 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.
Can a non-U.S. (foreign) institution apply as the main applicant?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as applicant organizations.
Can a non-U.S. component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply.
Are any international activities or collaborations allowed at all?
Yes. "Foreign components" (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain well-justified international elements or collaborations if they meet NIH policy requirements and are appropriately structured.
What is the CFDA number for this opportunity?
The opportunity is listed under CFDA 93.855.
When was this opportunity created, and what was the closing date listed?
The creation date is May 7, 2021, and the original closing date listed is August 4, 2021.
Is the award ceiling provided?
No. The award ceiling is not specified in the provided information.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided information.
What is the big-picture outcome NIH is trying to achieve with this program?
The program is intended to produce actionable, mechanistic and translational insights (primarily from NHP studies) that accelerate the design and refinement of future HIV vaccines and immune-based cure approaches, supporting a stronger evidence base for eventual clinical evaluation under other pathways.
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