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

Inclusion criteria

• Able to understand and provide informed consent
• Individual ≥ 18 years of age.
• Recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment
• Maintenance immunosuppressive regimen consisting of CNI and mycophenolate mofetil or mycophenolate, with or without ≤ 5mg/day prednisone or equivalent
• Received completed primary series (3 doses) of mRNA vaccine (either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) as specified in the respective package inserts
• Receipt a COVID-19 bivalent mRNA booster (Moderna or Pfizer-BioNTech) >30 days prior to enrollment.
• Serum antibody titer up to 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(R) anti-SARS-CoV-2 S assay
• Platelet count greater than 30,000/cu mm must be confirmed in participants with a known history of bleeding disorder or thrombocytopenia (platelet count <50,000/cu mm)
• A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

• Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile

OR

• Is of childbearing potential and agrees to use an effective contraceptive method or abstinence for 12 weeks post vaccine and while taking mycophenolate mofetil/mycophenolic acid

Exclusion criteria

• 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
• Recipient of any organ other than a kidney
• Known current or prior Donor Specific Antibody (DSA)
• Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
• Known diagnosis of COVID-19 since last antibody test
• Receipt of a monoclonal antibody product or convalescent plasma within the last 30 days
• 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)
• Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
• 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
• Receipt of any vaccine in the 30 days preceding the study vaccine or planned vaccines in the 30 days following the study vaccine
• Estimated Glomerular Filtration Rate <30mL/min/1.73m^2
• Receipt of any cellular depleting agent (e.g. Antithymocyte globulin (ATG), Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
• Receiving systemic immunomodulatory medication(s) for any condition other than transplant
• Any uncontrolled active infection
• Infection with human immunodeficiency virus (HIV)
• Maintenance immunosuppressive regimen that includes anything other than a CNI, mycophenolate/mycophenolate mofetil, and ≤ 5mg/day prednisone or equivalent
• Recent (within one year) or ongoing treatment for malignancy, except for definitive surgical treatment of localized skin cancers
• 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