NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

The National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services, is offering a funding opportunity for investigator-initiated, high-risk clinical trials through the NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required). This Notice of Funding Opportunity (NOFO), identified as PAR-24-100, represents a reissue of PAR-21-083 and is designed to support the implementation of a single, high-risk clinical trial per application that aligns with the NIAID’s mission and high-priority research areas. Mechanistic studies within clinical trials are encouraged and required for some divisions. The goal of this funding opportunity is to foster clinical trials that address important questions in infectious, immunologic, and allergic diseases, including HIV. These trials must be hypothesis-driven and aim to understand disease mechanisms or inform the development of new therapeutic strategies. The clinical trials supported under this NOFO must qualify as high-risk, which includes trials involving non-routine interventions, unlicensed products, or licensed products used for unapproved indications. Applicants must be ready for trial implementation at the time of award, as planning activities are not funded under this mechanism. Funding under this NOFO may be used for comprehensive clinical trial activities such as personnel training, recruitment, data collection and analysis, study oversight, and regulatory compliance. Specific costs such as investigational products and related logistics may also be supported. All clinical laboratory testing must comply with federal regulations, and protocols are subject to internal NIAID review before trial initiation. Each grant will support a single trial, though platform trials with multiple interventions or sequential stages are permissible. Eligibility for this funding opportunity is broad, encompassing higher education institutions, non-profits, for-profits, government entities, public housing authorities, tribal organizations, regional organizations, and foreign institutions. Applicant organizations must complete several federal registrations, including SAM, UEI, eRA Commons, and Grants.gov. Individuals eligible to apply include those with the necessary skills and resources to conduct the research. Applications are due on scheduled cycles through January 2027, with the final expiration date moved up to May 24, 2025, per notice NOT-OD-25-113. Letters of intent are requested 30 days prior to the application due date. Applications must comply with detailed requirements, including a complete protocol and data and safety monitoring plan, and must be submitted electronically through NIH-approved systems. Applicants requesting $500,000 or more in direct costs in any year must consult NIAID staff at least 10 weeks before submission. Contacts for this funding opportunity include Martin Gutierrez (DAIDS), Ellen Goldmuntz (DAIT), and the DMID IICT Central Contact Mailbox for scientific inquiries. Financial and peer review contacts are also provided. Applications are peer-reviewed based on scientific merit, with final decisions made considering merit, relevance, and budget sufficiency.