COVID Protection After Transplant-Immunosuppression Reduction

Completed · Phase 2

Conditions studied: Kidney Transplant Recipients, Liver Transplant Recipients

In brief

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.

Key facts

Study ID

NCT05077254

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Starts

2021-12-06

Expected to finish

2025-02-21

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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-
• Currently on an immunosuppressive regimen different from the three regimens described in the Inclusion Criteria, for example (but not limited to) those including sirolimus, everolimus, belatacept, or azathioprine
• 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)
• 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)
• Treatment or prophylaxis of COVID-19 with a monoclonal antibody product or convalescent plasma within 6 months preceding enrollment, or
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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