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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 naive | 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. |
| |
| SARS-Cov-2 exposed | 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. |
| |
| Waiting list | Kidney transplant recipients who were vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-Cov-2 exposed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-spike SARS-CoV-2 IgG | Diagnostic Test | Immunochemiluminescent assay by DiaSorin S.p.A. Italy |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Kidney transplant recipients vaccinated with 2 doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Ondrej Viklicky, Prof. | Institute for Clinical and Experimental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine | Prague | 140 21 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37027078 | Derived | Schmalz M, Vankova H, Rajnochova-Bloudickova S, Hruba P, Fialova M, Gurka J, Magicova M, Striz I, Zahradka I, Viklicky O. The impact of frailty syndrome on humoral response to SARS-CoV-2 mRNA vaccines in older kidney transplant recipients. Int Urol Nephrol. 2023 Nov;55(11):2959-2965. doi: 10.1007/s11255-023-03557-6. Epub 2023 Apr 7. | |
| 34999659 |
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blood
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 |
| Magicova M, Zahradka I, Fialova M, Neskudla T, Gurka J, Modos I, Hojny M, Raska P, Smejkal P, Striz I, Viklicky O. Determinants of Immune Response to Anti-SARS-CoV-2 mRNA Vaccines in Kidney Transplant Recipients: A Prospective Cohort Study. Transplantation. 2022 Apr 1;106(4):842-852. doi: 10.1097/TP.0000000000004044. |