COVID Protection After Transplant - Sanofi GSK (CPAT-SG) Study (CPAT-SG)
COVID-19, Kidney Transplant
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Kidney transplant, COVID-19, Vaccine
Eligibility Criteria
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
Sites / Locations
- University of California San Diego Medical Center: Transplantation
- UCSF School of Medicine: Transplantation
- Emory University School of Medicine: Transplantation
- University of Illinois Medical Center: Transplantation
- Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research UnitRecruiting
- University of Wisconsin School of Medicine and Public Health: Transplantation
Arms of the Study
Arm 1
Experimental
Kidney transplant recipients
This single-arm trial will administer a single dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine to kidney transplant recipients who demonstrate a persistently low (=< 2500 u/mL) anti-spike antibody response after completion of primary series and bivalent booster of either the Moderna COVID-19 Vaccine or the Pfizer-BioNTech Vaccine, as described in their respective Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs)