The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine.
TASMANIA is a single-center prospective observational study with 1000 kidney transplant recipients from Institute for Clinical and Experimental Medicine (IKEM), Prague. The primary objective of the study is to assess humoral immune response to SARS-CoV-2 mRNA vaccines in SARS-CoV-2-naive kidney transplant recipients using immunochemiluminescent assay. As comparator several cohorts will be evaluated: 1. kidney transplant recipients with previous SARS-CoV-2 exposition verified by real-time reverse transcription polymerase chain reaction (RT-PCR) 2. kidney transplant recipients vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-CoV-2 previously exposed The secondary objective is to determine clinical variables affecting antibody levels. SARS-CoV-2 anti S1/2 antibodies will be tested ≥ 15 days after the second dose of mRNA vaccines and in 3 months after the first blood sampling. In subanalysis 50 kidney transplant recipients will be examined for a cell-mediated immune response after SARS-CoV-2 mRNA vaccine Enzyme Linked using Immuno Spot (ELISPOT) assay.
Study Type
OBSERVATIONAL
Enrollment
753
Immunochemiluminescent assay by DiaSorin S.p.A. Italy
Institute for Clinical and Experimental Medicine
Prague, Czechia
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination
Time frame: 15 days-90 days
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
anti-spike SARS-CoV-2 IgG measured 3 ≥ months after the first blood sampling
Time frame: 3 months - 6 months
Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
Cellular immunity measured by ELISPOT assay in subgroup of 50 patients
Time frame: 15 - 90 days
Graft function after vaccination
Estimated glomerular filtration rate (eGFR)
Time frame: 15 days-90 days
Clinical variables affecting antibody levels
Sex, previous SARS-CoV-2 infection, Age, Retransplantation, BMI, time from transplant, eGFR, diabetes mellitus, use of imunosuppression (tacrolimus, cyclosporine A, CNI-free regimen, mycophenolate mofetil, depleting therapy).
Time frame: 15 days-90 days
The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination
Fried frailty score
Time frame: 15 days-90 days
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