IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation (TASMANIA)

Study Overview
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Brief Summary
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The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine.

Detailed Description
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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: kidney transplant recipients with previous SARS-CoV-2 exposition verified by real-time reverse transcription polymerase chain reaction (RT-PCR) 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.

Official Title
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IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Diagnostic Test: anti-spike SARS-CoV-2 IgG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplant recipients Recipient age ≥ 18 years Written Informed Consent and Consent for Processing Personal Data Vaccination with two doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation. Exclusion Criteria: Active SARS-CoV-2 infection. Patients that received anti-SARS-CoV-2 monoclonal antibodies. Active infection after vaccination Monoclonal antibodies treatment ahead of antibody or cellular immunity screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 naive<br>Kidney transplant recipients without previous SARS-CoV-2 infection verified by absence of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. | Diagnostic Test: anti-spike SARS-CoV-2 IgG<br>* Immunochemiluminescent assay by DiaSorin S.p.A. Italy<br>|
| SARS-Cov-2 exposed<br>Kidney transplant recipients with previous SARS-CoV-2 exposition verified by positivity of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. | Diagnostic Test: anti-spike SARS-CoV-2 IgG<br>* Immunochemiluminescent assay by DiaSorin S.p.A. Italy<br>|
| Waiting list<br>Kidney transplant recipients who were vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-Cov-2 exposed | Diagnostic Test: anti-spike SARS-CoV-2 IgG<br>* Immunochemiluminescent assay by DiaSorin S.p.A. Italy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. | anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination | 15 days-90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 15 - 90 days | 
| Graft function after vaccination | Estimated glomerular filtration rate (eGFR) | 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). | 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 | 15 days-90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, SARS-CoV-2, humoral immunity