COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study

Exclusion Criteria

• •1. Recipient of any number of doses of any COVID vaccine product other than the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine
• •2. Recipient of any organ other than a kidney
• •3. Known current or prior Donor Specific Antibody (DSA)
• •4. Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
• •5. Known diagnosis of COVID-19 since last antibody test
• •6. Receipt of a monoclonal antibody product or convalescent plasma within the last 30 days
• •7. Known history of hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. (components listed in Section 6, and the CoV2 and AS03 Investigator's Brochure)
• •8. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
• •9. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
• •10. Receipt of any vaccine in the 30 days preceding the study vaccine or planned vaccines in the 30 days following the study vaccine
• •11. Estimated Glomerular Filtration Rate \<30mL/min/1.73m\^2
• •12. Receipt of any cellular depleting agent (e.g. Antithymocyte globulin (ATG), Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
• •13. Receiving systemic immunomodulatory medication(s) for any condition other than transplant
• •14. Any uncontrolled active infection
• •15. Infection with human immunodeficiency virus (HIV)
• •16. Maintenance immunosuppressive regimen that includes anything other than a CNI, mycophenolate/mycophenolate mofetil, and ≤ 5mg/day prednisone or equivalent
• •17. Recent (within one year) or ongoing treatment for malignancy, except for definitive surgical treatment of localized skin cancers
• •18. Any unstable acute or chronic illness, treatments, or findings which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the c candidate's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study