Kidney Transplantation
Conditions
Keywords
kidney transplantation, SARS-CoV-2, humoral immunity
Brief summary
The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTanti-spike SARS-CoV-2 IgG
Immunochemiluminescent assay by DiaSorin S.p.A. Italy
Sponsors
Institute for Clinical and Experimental Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. | 15 days-90 days | anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. | 3 months - 6 months | anti-spike SARS-CoV-2 IgG measured 3 ≥ months after the first blood sampling |
| Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. | 15 - 90 days | Cellular immunity measured by ELISPOT assay in subgroup of 50 patients |
| Graft function after vaccination | 15 days-90 days | Estimated glomerular filtration rate (eGFR) |
| Clinical variables affecting antibody levels | 15 days-90 days | 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). |
| The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination | 15 days-90 days | Fried frailty score |
Countries
Czechia
Outcome results
None listed