COVID Protection After Transplant-Immunosuppression Reduction

You may be eligible if

• Individuals who meet all the following criteria are eligible for enrollment as study participants-
• 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.