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PAR-21-083: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Closed Closed January 13, 2024 Opportunity PAR-21-083

This grant is closed. A newer notice from the same program is open now: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) (PAR-27-064). Status: Due dates in the notice, expires July 5, 2029. It is in our archive of National Institutes of Health notices from 2021.

National Institutes of Health offered grants to small businesses. Applications closed on January 13, 2024.

From the official notice on Grants.gov, last changed January 14, 2021. Checked November 7, 2026.

About this NIH notice

Projects funded under PAR-21-083 were run by National Institute of Allergy and Infectious Diseases (NIAID, 25 projects). Contact the program officer at the institute that fits your project before you apply; the notice lists them.

Application due dates, page limits and budget limits are set in the notice. Read PAR-21-083 in the NIH Guide.

Other notices with this title

National Institutes of Health has posted this title under other numbers: earlier or later rounds, or the same competition for another area. Each has its own dates and may change its rules.

NoticePostedDeadlineStatus
PAR-27-064June 16, 2026Due dates in the notice, expires July 5, 2029Open
PAR-24-100January 29, 2024Closed May 23, 2025Closed

Key dates

PostedJanuary 14, 2021
DeadlineJanuary 13, 2024
Archived by Grants.govFebruary 18, 2024

Who can apply

This opportunity was open to small businesses.

More grants for small businesses.

Is this a realistic fit?

What the grant funds

This Funding Opportunity Announcement (FOA) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. 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. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role). Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application.

Category: Health.

Funded under PAR-21-083 so far

NIH funded 25 projects under PAR-21-083 in fiscal 2022 to 2026, at 20 institutions. The median yearly award was $1.0 million.

Most projects: Johns Hopkins University (Maryland), 3, University of California, San Francisco (California), 3, Vanderbilt University Medical Center (Tennessee), 2, University of California Los Angeles (California), 1, Duke University (North Carolina), 1.

Recently funded projects
ProjectInstitutionFiscal yearAward
A Phase 1/2a, randomized study of a Tfh-targeting genetic vaccine adjuvant designed to induce broad, durable immune responses U01University of California Los Angeles2026$1.4 million
A Randomized Controlled Trial of Prophylaxis with Direct-acting Antivirals for Kidney Transplantation from Hepatitis C virus-infected donor to Uninfected Recipients (PREVENT-HCV) U01Johns Hopkins University2026$976,602
Improving Neonatal health Through Rapid malaria testing in Early Pregnancy with high-sensitivity Diagnostics (INTREPiD) U01Duke University2026$960,411
Safety and efficacy of Belatacept in heart transplantation U01New York University School of Medicine2026$2.0 million
A Phase II Controlled Trial of Allogeneic Mesenchymal Stromal Cells for the Treatment of Refractory Lupus (MiSLE) U01Medical University of South Carolina2026$1.3 million
Mechanistic clinical trial of blocking the IL-4/13 axis in asthmatics precision phenotyped in an aeroallergen challenge chamber before, during and after receipt of dupilumab U01University of Texas HLTH Science Center2026$1.2 million
Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh U01Johns Hopkins University2026$258,400
PRESCIENT: A phase IIc, open-label, randomized controlled trial of ultra-short course bedaquiline, clofazimine, pyrazinamide and delamanid versus standard therapy for drug-susceptible tuberculosis U01Brigham and Women's Hospital2026$365,441

From NIH RePORTER, which lists each project once per fiscal year it was funded. Amounts are the yearly award.

Who has won Allergy and Infectious Diseases Research grants before

From fiscal 2021 to 2025, Allergy and Infectious Diseases Research (93.855) awarded $22 billion across 13,282 grant awards, an average of $1.6 million per award.

Largest recipients, fiscal 2021 to 2025
RecipientStateAwardsAmount
Fred Hutchinson Cancer CenterWashington85$938 million
Duke UniversityNorth Carolina230$781 million
University of California, Los AngelesCalifornia138$745 million
The Johns Hopkins UniversityMaryland321$668 million
Emory UniversityGeorgia282$650 million

Top states: California ($3.4 billion), Massachusetts ($2.1 billion), Washington ($1.9 billion), New York ($1.8 billion), North Carolina ($1.5 billion).

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-064, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.

Questions people ask

Is PAR-21-083 still open?

No. It closed on January 13, 2024. A newer notice is open: PAR-27-064, due dates in the notice, expires July 5, 2029.

Who can apply for NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)?

National Institutes of Health accepted applications from small businesses.

What is the deadline for NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)?

Closed January 13, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.

Who has been funded under PAR-21-083?

NIH RePORTER lists 25 projects funded under PAR-21-083 in fiscal 2022 to 2026, at 20 institutions. The most were at Johns Hopkins University, University of California, San Francisco, Vanderbilt University Medical Center.

Who has won Allergy and Infectious Diseases Research grants before?

The largest recipients over five fiscal years were Fred Hutchinson Cancer Center, Duke University, University of California, Los Angeles. The program made 13,282 awards worth $22 billion in that time.

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