NIH PAR · NIAID · U01
PAR-27-064: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
Reviewed by Dr. Meng ZhaoLast reviewed October 16, 2026Data refreshed October 16, 2026Editorial standards
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…
- NOFO number
- PAR-27-064
- Type
- PAR
- Activity code
- U01
- Primary institute
- NIAID · National Institute of Allergy and Infectious Diseases
- Clinical trials
- Required
- Posted
- Jun 16, 2026
- Opens
- Sep 5, 2026
- Expires
- Jul 6, 2029
PAR-27-064 due dates
8 application due dates remain before the NOFO expires. Dates marked * are NIH standard due dates. Check the related notices below for changes NIH made after posting.
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
|---|---|---|---|---|---|
| October 05, 2026 * | November 05, 2026 * | Not Applicable | March 2027 | May 2027 | July 2027 |
| February 05, 2027 * | March 05, 2027 * | Not Applicable | July 2027 | October 2027 | December 2027 |
| June 05, 2027 * | July 05, 2027 * | Not Applicable | November 2027 | January 2028 | April 2028 |
| October 05, 2027 * | November 05, 2027 * | Not Applicable | March 2028 | May 2028 | July 2028 |
| February 05, 2028 * | March 05, 2028 * | Not Applicable | July 2028 | October 2028 | December 2028 |
| June 05, 2028 * | July 05, 2028 * | Not Applicable | November 2028 | January 2029 | April 2029 |
| October 05, 2028 * | November 05, 2028 * | Not Applicable | March 2029 | May 2029 | July 2029 |
| February 05, 2029 * | March 05, 2029 * | Not Applicable | July 2029 | October 2029 | December 2029 |
| June 05, 2029 * | July 05, 2029 * | Not Applicable | November 2029 | January 2030 | April 2030 |
What its predecessor PAR-24-100 funded
PAR-27-064 reissues PAR-24-100. Until awards appear under the new number, its funding history is the best guide to who wins under this program: 18 projects and $38.2M in FY2022–FY2026.
Projects funded
18
Distinct projects, FY2022–FY2026
New awards
16
Type 1 (new project) award records
NIH funding
$38.2M
Award dollars under PAR-24-100, FY2022–FY2026
Funding by fiscal year
| Fiscal year | Award records | New awards | Funding |
|---|---|---|---|
| FY2022 | 0 | 0 | $0 |
| FY2023 | 0 | 0 | $0 |
| FY2024 | 0 | 0 | $0 |
| FY2025 | 17 | 9 | $16.0M |
| FY2026 | 23 | 7 | $22.2M |
Institutions with the most funding
- Duke University$7.0M · 1 project
- Johns Hopkins University$5.5M · 2 projects
- University of California, San Francisco$4.5M · 2 projects
- Boston Children's Hospital$3.8M · 2 projects
- Oregon Health & Science University$2.9M · 1 project
- University of Wisconsin-Madison$2.9M · 1 project
- University of Alabama at Birmingham$2.3M · 1 project
- Emory University$1.9M · 1 project
Funding institutes
- NIAID$38.2M · 40
Activity codes funded
- U0140 records
Most recent new awards
- Strategy Trial of Personalized Immunomodulatory Therapy for HIV-related Cryptococcal Meningitis (opens NIH RePORTER)
University of Minnesota · 1U01AI198071-01 · NIAID · Notice Sep 2, 2026
$331KU01
- Characterising the pharmacokinetics of tafenoquine for Plasmodium vivax radical cure in children ≥12 kg and >28 days old (opens NIH RePORTER)
University of Oxford · 1U01AI195203-01 · NIAID · Notice Aug 4, 2026
$525KU01
- Early antiviral treatment to prevent viral persistence and inflammation as drivers of Long COVID: a proof-of-concept mechanistic trial (opens NIH RePORTER)
University of California, San Francisco · 1U01AI192043-01A1 · NIAID · Notice Jul 21, 2026
$1.7MU01
- Combination Antibiotic Therapy for Pseudomonas VAP (CombAT Pseudo VAP): A Pragmatic Trial (opens NIH RePORTER)
Northwestern University · 1U01AI189337-01A1 · NIAID · Notice Jul 14, 2026
$1.5MU01
- Congenital Syphilis Treatment Trial (CONSISTENT): Phase IV, Open-label, Randomized Controlled Trial of Amoxicillin vs Benzathine Penicillin in Neonates with Possible Congenital Syphilis (opens NIH RePORTER)
University of Alabama at Birmingham · 1U01AI195199-01 · NIAID · Notice May 12, 2026
$2.3MU01
- Immunogenicity and Safety of High-Dose vs. Standard-Dose Influenza Vaccines Administered Over Consecutive Seasons to Lung Transplant Recipients (opens NIH RePORTER)
Vanderbilt University Medical Center · 1U01AI195200-01 · NIAID · Notice Apr 13, 2026
$888KU01
FY2026 closed on September 30, 2026, but NIH keeps posting that year's awards to RePORTER for several weeks. FY2026 figures reflect records available on October 16, 2026 and may rise slightly at the next refresh.
Participating institutes
2 NIH institutes and offices take applications under PAR-27-064. Contact the program officer at the institute that fits your research before applying.
- NIAID · National Institute of Allergy and Infectious Diseases
- none
Related notices
NIH lists no related notices for PAR-27-064 yet.
Award terms
- Application types allowed
- New Renewal Resubmission Revision The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
- Award budget
- Application budgets are not limited but need to reflect the actual needs of the proposed project.
- Project period
- The scope of the proposed project should determine the project period. The expectation is that most trials will be completed within 5 years, however, the maximum project period is 7 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
- Funds available and number of awards
- The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Summarized from the NOFO text; the full NOFO governs eligibility, budget, and review.
Related NOFOs
- Reissue of PAR-24-100.
Other open NOFOs for U01
- RFA-AI-27-014Development of Candidate Medical Countermeasures (MCMs) and Technologies Against Radiological/Nuclear or Chemical Threats (U01 Clinical Trial Not Allowed)NIAID · next due Nov 9, 2026
- PAR-26-116Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)OD · next due Feb 5, 2027
- RFA-CA-27-019Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional)NCI · next due Oct 19, 2026
- RFA-DE-27-001Community Engagement Evaluation and Data Coordination (CEED) Hub to Advance Data and Practice Transformation for Optimizing Oral Health for All (U01, Clinical Trial Not Allowed)NIDCR · next due Oct 19, 2026
- PAR-25-343NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)NIDCD · next due Oct 19, 2026
- PAR-25-352National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)NIMH · next due Oct 25, 2026
About this page
GotGrant gathers the NOFO, its participation and change notices, and its NOSIs from the NIH Guide for Grants and Contracts, and counts funded projects from NIH RePORTER by the opportunity number each award was made under. Data refreshed October 16, 2026; the NIH Guide is the authoritative source. See our data methodology.