Vaccine and Treatment Evaluation Units (VTEUs): Enhancing Capability and Capacity (UM1 Clinical Trial Required) | RFA AI 20 021

Opportunity Information: Apply for RFA AI 20 021

The Vaccine and Treatment Evaluation Units (VTEUs): Enhancing Capability and Capacity opportunity (RFA-AI-20-021) is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) funding announcement that supports a network of clinical sites responsible for carrying out NIAID-sponsored infectious disease clinical research and clinical trials. The award mechanism is a UM1 cooperative agreement, which means funded sites do not operate in isolation; they work in close partnership with NIAID under a substantial federal involvement model. The core aim is to strengthen and expand the real-world ability of these sites to rapidly design, start, and conduct high-quality clinical studies that evaluate medical products for infectious diseases, including vaccines and other preventive biologics, therapeutics, diagnostics, and related tools such as prognostic and predictive markers and certain devices used for prevention and treatment.

This program sits within the NIAID Infectious Diseases Clinical Research Consortium (IDCRC). In practice, the VTEUs function as the on-the-ground execution arm of the consortium: they implement clinical site protocols, enroll and follow participants, collect and manage study data and specimens, and ensure compliance with regulatory and ethical requirements. The types of studies supported can span clinical research and clinical trials, and the emphasis is on product evaluation rather than purely observational science. A companion funding announcement supports a separate Leadership Group (LG) that provides overall scientific direction and administrative coordination for the consortium. The VTEUs and the Leadership Group are meant to operate as an integrated system, with the LG guiding consortium-wide priorities and operations while the VTEUs provide the staffing, infrastructure, and participant access needed to run studies efficiently and consistently across locations.

Scientifically, the program prioritizes NIAID high-need infectious disease areas. The announcement highlights malaria and neglected tropical diseases, sexually transmitted infections, respiratory infections, and enteric diseases as key focus areas where new or improved vaccines, therapeutics, and diagnostics are especially important. At the same time, the VTEU network is expected to maintain surge capacity for emerging infectious diseases. That surge requirement is a major operational expectation: sites must be able to pivot quickly when an outbreak or new threat appears, scaling up staffing and procedures, launching urgent protocols, and supporting rapid enrollment and data generation when timelines are compressed and public health needs are acute.

From an applicant eligibility standpoint, the opportunity is broadly open to many U.S.-based organizational types, reflecting the practical reality that clinical trial capacity can be housed in universities, hospitals, nonprofits, private entities, and government bodies. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education under that category); for-profit organizations other than small businesses; and small businesses. The announcement also calls out additional categories that are explicitly welcomed as eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American 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, regional organizations, and U.S. territories or possessions. These inclusions signal an interest in building a diverse, geographically and demographically broad clinical research footprint that can reach varied participant populations.

There are also clear boundaries around non-U.S. participation. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply as the main applicant organization. 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.-based awardee can include certain foreign elements as part of the overall project when they are well-justified and consistent with NIH policy. This structure supports U.S.-led clinical trial operations while still permitting limited international collaboration or activities when they are essential to the science or the public health objective.

Administratively, the listing is a discretionary funding opportunity in the health category (CFDA 93.855) using the cooperative agreement funding instrument. The original closing date was July 14, 2020, and the opportunity was created on February 19, 2020. The posted award ceiling is $400,000, although cooperative agreement budgets and the real total cost of operating trial-ready infrastructure can vary depending on NIH terms, specific protocol demands, and consortium needs. Overall, the opportunity is best understood as funding for durable clinical trial capacity: building and maintaining sites that can reliably deliver rigorous infectious disease product evaluation studies in priority areas while also being ready to mobilize quickly when new infectious threats emerge.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Vaccine and Treatment Evaluation Units (VTEUs): Enhancing Capability and Capacity (UM1 Clinical Trial Required)" 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 2020-02-19.
• Applicants must submit their applications by 2020-07-14. (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 $400,000.00 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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