COVID Protection After Transplant-Immunosuppression Reduction
NCT ID: NCT05077254
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2021-12-06
2025-02-21
Brief Summary
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* 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.
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Detailed Description
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Participants will be randomized to either:
1. Receive a study dose of mRNA based COVID-19 vaccine (booster) with no change in their immunosuppressive regimen, or
2. Undergo a temporary, prescribed reduction in their maintenance immunosuppression (IS) regimen and receive a study dose (booster) of mRNA based COVID-19 vaccine.
Protocol Version 8.0 will include a booster dose of either Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or Moderna COVID-19 Vaccine 2023-2024, with or without IS reduction.
Duration of study participation for interested and eligible individuals: 13 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* A study dose of mRNA COVID-19 vaccine only, or
* Immunosuppression (IS) reduction plus a study dose of mRNA COVID-19 vaccine. IS reduction will be based on the participant's IS regimen upon study entry, in accordance with the study's protocol.
TREATMENT
NONE
Study Groups
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Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Regimen
Participants 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
Administration: One dose administered intramuscularly.
SOC IS Regimen
Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Reduction
Participants 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
Pfizer-BioNTech COVID-19 Vaccine 2023-2024
Administration: One dose administered intramuscularly.
SOC IS Reduction
Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.
Moderna COVID-19 Vaccine 2023-2024 + SOC IS Regimen
Participants 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
Administration: One dose administered intramuscularly.
SOC IS Regimen
Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
Moderna COVID-19 Vaccine 2023-2024 + SOC IS Reduction
Participants 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
Moderna COVID-19 Vaccine 2023-2024
Administration: One dose administered intramuscularly.
SOC IS Reduction
Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.
Interventions
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Pfizer-BioNTech COVID-19 Vaccine 2023-2024
Administration: One dose administered intramuscularly.
Moderna COVID-19 Vaccine 2023-2024
Administration: One dose administered intramuscularly.
SOC IS Regimen
Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
SOC IS Reduction
Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Able to understand and provide informed consent
2. Individual ≥18 years of age.
3. Recipient of a kidney or liver transplant ≥12 months prior to enrollment, without allograft rejection in the 6 months preceding enrollment
4. Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening (Central Lab Test Determination).
5. 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
6. Received a minimum of 3 doses of either the Moderna coronavirus infectious disease 19 (COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine
7. 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.
8. 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.
9. 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.
2. Recipient of any allograft other than a kidney or liver
3. Participant is pregnant
4. Any past history of Donor Specific Antibody (DSA) using local site standards
5. Prior receipt of the Moderna COVID-19 Vaccine 2023-2024 or Pfizer-BioNTech COVID-19 Vaccine 2023-2024.
6. Currently taking any systemic immunosuppressive agent, other than their prescribed transplant immunosuppression
7. Known history of severe allergic reaction to any component of an authorized or licensed COVID-19 vaccine
8. Thrombotic events, myocarditis, or pericarditis temporally associated with a prior dose of COVID-19 vaccine
9. History of heparin-induced thrombocytopenia
10. Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
11. More than minimal graft dysfunction, in accordance with study definition
12. Receipt of any cellular depleting agent (e.g. antithymocyte globulins (ATG), rituximab, alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
13. Concurrent autoimmune disease at risk for exacerbation with immunosuppression reduction
14. Any untreated active infection including BK viremia \>10\^4 copies
15. Infection with human immunodeficiency virus (HIV)
16. Recent (within one year) or ongoing treatment for malignancy with the exception of:
* Non- melanomatous skin cancer definitively treated by local therapy, and
* Definitively treated carcinoma-in-situ of the cervix (Stage 0 cervical cancer)
17. Treatment or prophylaxis of COVID-19 with a monoclonal antibody product or convalescent plasma within 6 months preceding enrollment, or
18. Any past or current medical problems, treatments, or findings which, in the opinion of the investigator, may:
* pose additional risks from participation in the study,
* interfere with the candidate's ability to comply with study requirements, or
* impact the quality or interpretation of the data obtained from the study.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
Johns Hopkins University
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Dorry L. Segev, MD, PhD
Role: STUDY_CHAIR
Transplant Surgery, Johns Hopkins University School of Medicine
Peter S. Heeger, MD
Role: STUDY_CHAIR
Translational Transplant Research Center, Icahn School of Medicine at Mount Sinai
Christian P. Larsen, MD, DPhil
Role: STUDY_CHAIR
Emory Transplant Center, Emory University School of Medicine
Locations
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University of California, San Diego
San Diego, California, United States
University of California San Francisco Health
San Francisco, California, United States
Emory Healthcare
Atlanta, Georgia, United States
University of Illinois Health
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
Ochsner Health
New Orleans, Louisiana, United States
Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit
Baltimore, Maryland, United States
NYU Langone Transplant Institute
New York, New York, United States
Mt. Sinai Hospital
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Houston Methodist
Houston, Texas, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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References
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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.
Related Links
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National Institute of Allergy and Infectious Diseases
Division of Allergy, Immunology, and Transplantation
Other Identifiers
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NIAID CRMS ID#: 38892
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT COVID19-TB-03
Identifier Type: -
Identifier Source: org_study_id
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