health · HHS-NIH11

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

National Institutes of Health · PAR-27-064

1059 days left

Deadline

July 5, 2029

GRANTQUICK SUMMARYPlain-English Overview

NIH/NIAID's Clinical Trial Implementation Cooperative Agreement (U01) is a standing NOFO for implementing clinical trials of vaccines, therapeutics, diagnostics, and prevention strategies for infectious diseases. Rolling deadline through 2029. No fixed award amounts — NIAID funds trials that address their priorities in HIV, TB, emerging infections, and antimicrobial resistance.

Who Should Apply

Academic medical centers and clinical research organizations with infrastructure to conduct multi-site infectious disease clinical trials. Must have clinical trial networks, IRB capacity, and patient populations.

Who Should NOT Apply

Basic science labs, institutions without clinical trial infrastructure, or researchers proposing observational studies (separate mechanism).

Key Requirements (Plain English)

•Must implement clinical trials for infectious disease interventions
•Must have clinical trial infrastructure and patient access
•Rolling deadline through July 2029
•No fixed award number or amount (depends on NIAID priorities)
•Cooperative agreement (NIAID involvement in trial design)
•No cost-sharing required

💡 GrantQuick Tip

NIAID U01 clinical trial cooperative agreements are the mechanism for large infectious disease trials (the COVID vaccine trials used this). You need to be in active dialogue with NIAID program officers about which trials they want to fund BEFORE submitting. Cold applications rarely succeed — this is a relationship-driven mechanism. If you have an infectious disease trial concept, contact the relevant NIAID division to gauge interest first.

Competitiveness: High — competitive review but relationship-driven. Established NIAID clinical trial networks have major advantages.

What This Grant Funds

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Attachments

PDF

PAR-27-064-Full-Announcement.html

Who Can Apply

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Eligible Applicant Types

Nonprofits without 501(c)(3)Other (see NOFO for details)State GovernmentsIndependent School DistrictsFederally Recognized Tribal GovernmentsPrivate Colleges & UniversitiesSpecial District GovernmentsCounty GovernmentsOther Tribal OrganizationsFor-Profit OrganizationsPublic And Indian Housing Authorities501(c)(3) NonprofitsSmall BusinessesCity/Township GovernmentsPublic Colleges & Universities

Funding Details

Cost Sharing Required?: No
Funding Instrument: cooperative_agreement

Key Dates

Posted: June 16, 2026

Application Deadline: July 5, 2029 (1059 days remaining)

Agency Contact

National Institute of Allergy and Infectious Diseases (NIAID) NIAID_IICT_U01@mail.nih.gov

NIAID_IICT_U01@mail.nih.gov

Ready to apply?

View the full NOFO and submit your application on Grants.gov

View on Grants.gov