COVID Protection After Transplant-Immunosuppression Reduction
CPAT-ISR
A Randomized Study to Evaluate Antibody Response to an Additional Dose of SARS-CoV-2 Vaccination With and Without Immunosuppression Reduction in Kidney and Liver Transplant Recipients
3 other identifiers
interventional
48
1 country
15
Brief Summary
This study will enroll individuals who have:
- Completed primary series of mRNA COVID-19 vaccine, and
- An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2021
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedStudy Start
First participant enrolled
December 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2025
CompletedResults Posted
Study results publicly available
April 23, 2026
CompletedApril 23, 2026
April 1, 2026
2.2 years
October 12, 2021
January 16, 2026
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The -Fold Change in Antibody Titer (Using the Roche Elecsys® Anti-SARS-CoV-2 S Assay) From Before Receiving the Study Dose of Vaccine to 30 Days After the Study Dose of Vaccine.
Serum antibody titer will be measured using the Roche Elecsys®) severe acute respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay. Values \> 1 represent increase from baseline; values \< 1 represent decrease from baseline.
Day 30 After Study Vaccination
Secondary Outcomes (15)
Frequency of Solicited Systemic Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine
Through Day 7 Post Study Vaccination
Proportion of Participants With Local Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Through Day 7 post Vaccine dose
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Through Day 7 post Vaccine dose
Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose
Through Day 7 post Vaccine dose
Frequency of Any Serious Adverse Events (SAEs) During the 30 Days Following the Additional Dose of Vaccine
Through Day 30 Post Study Vaccination
- +10 more secondary outcomes
Study Arms (4)
Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Regimen
EXPERIMENTALParticipants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. SOC IS: Standard of Care transplant immunosuppression regimen
Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Reduction
EXPERIMENTALParticipants will receive an additional dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024, with concurrent reduction of their standard of care transplant immunosuppression regimen (IS), per protocol. SOC IS Reduction: Standard of Care transplant immunosuppression regimen reduction, per protocol
Moderna COVID-19 Vaccine 2023-2024 + SOC IS Regimen
EXPERIMENTALParticipants will receive an additional dose (1 dose) of the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. SOC IS: Standard of Care transplant immunosuppression regimen
Moderna COVID-19 Vaccine 2023-2024 + SOC IS Reduction
EXPERIMENTALParticipants will receive a study dose (1 dose) of the Moderna COVID-19 Vaccine 2023-2024, with concurrent reduction of their standard of care transplant immunosuppression regimen (IS), per protocol. SOC IS Reduction: Standard of Care transplant immunosuppression regimen reduction, per protocol
Interventions
Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.
Administration: One dose administered intramuscularly.
Administration: One dose administered intramuscularly.
Eligibility Criteria
You may qualify if:
- Individuals who meet all the following criteria are eligible for enrollment as study participants-
- Able to understand and provide informed consent
- Individual ≥18 years of age.
- Recipient of a kidney or liver transplant ≥12 months prior to enrollment, without allograft rejection in the 6 months preceding enrollment
- Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening (Central Lab Test Determination).
- Currently taking one of the following tacrolimus-based immunosuppressive regimens:
- Tacrolimus plus Mycophenolate Mofetil (MMF) or Mycophenolic Acid (MPA), with or without a corticosteroid
- Tacrolimus with trough ≥ 5ng/mL with or without ≤5 mg of prednisone or equivalent
- Received a minimum of 3 doses of either the Moderna coronavirus infectious disease 19 (COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine
- Participant must be ≥ 60 days after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent or bivalent COVID-19 vaccine at the time of study vaccine.
- Serum antibody negative or low (titer ≤ 2500 U/mL) at ≥ 30 days from the last dose of mRNA COVID-19 vaccine and ≥ 30 days following receipt of a monoclonal antibody product or convalescent plasma for COVID-19, measured using the Roche Elecsys® anti-SARS-CoV-2 S assay.
- Participant's transplant physician or midlevel practitioner who is clinically licensed to prescribe and manage immunosuppression must confirm the participant's eligibility based on medical history.
You may not qualify if:
- Individuals who meet any of these criteria are not eligible for enrollment as study participants-
- Recipient of any allograft other than a kidney or liver
- Participant is pregnant
- Any past history of Donor Specific Antibody (DSA) using local site standards
- Prior receipt of the Moderna COVID-19 Vaccine 2023-2024 or Pfizer-BioNTech COVID-19 Vaccine 2023-2024.
- Currently taking any systemic immunosuppressive agent, other than their prescribed transplant immunosuppression
- Known history of severe allergic reaction to any component of an authorized or licensed COVID-19 vaccine
- Thrombotic events, myocarditis, or pericarditis temporally associated with a prior dose of COVID-19 vaccine
- History of heparin-induced thrombocytopenia
- Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
- More than minimal graft dysfunction, in accordance with study definition
- Receipt of any cellular depleting agent (e.g. antithymocyte globulins (ATG), rituximab, alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
- Concurrent autoimmune disease at risk for exacerbation with immunosuppression reduction
- Any untreated active infection including BK viremia \>10\^4 copies
- Infection with human immunodeficiency virus (HIV)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of California, San Diego
San Diego, California, 92093, United States
University of California San Francisco Health
San Francisco, California, 94143, United States
Emory Healthcare
Atlanta, Georgia, 30322, United States
University of Illinois Health
Chicago, Illinois, 60612, United States
Northwestern University
Evanston, Illinois, 60208, United States
University of Iowa Hospitals
Iowa City, Iowa, 52242, United States
Ochsner Health
New Orleans, Louisiana, 70121, United States
Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit
Baltimore, Maryland, 21287, United States
NYU Langone Transplant Institute
New York, New York, 10016, United States
Mt. Sinai Hospital
New York, New York, 10029, United States
Weill Cornell Medicine
New York, New York, 10065, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53706, United States
Related Publications (1)
Werbel WA, Boyarsky BJ, Ou MT, Massie AB, Tobian AAR, Garonzik-Wang JM, Segev DL. Safety and Immunogenicity of a Third Dose of SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series. Ann Intern Med. 2021 Sep;174(9):1330-1332. doi: 10.7326/L21-0282. Epub 2021 Jun 15. No abstract available.
PMID: 34125572BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Operations Program
- Organization
- DAIT/NIAID
Study Officials
- STUDY CHAIR
Dorry L. Segev, MD, PhD
Transplant Surgery, Johns Hopkins University School of Medicine
- STUDY CHAIR
Peter S. Heeger, MD
Translational Transplant Research Center, Icahn School of Medicine at Mount Sinai
- STUDY CHAIR
Christian P. Larsen, MD, DPhil
Emory Transplant Center, Emory University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 14, 2021
Study Start
December 6, 2021
Primary Completion
February 28, 2024
Study Completion
February 21, 2025
Last Updated
April 23, 2026
Results First Posted
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- On average, within 24 months after database lock for the trial.
- Access Criteria
- Open access.
The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.