IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation (TASMANIA)
- Conditions
- Kidney Transplantation
- Interventions
- Diagnostic Test: anti-spike SARS-CoV-2 IgG
- Registration Number
- NCT04832841
- Lead Sponsor
- Institute for Clinical and Experimental Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 753
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SARS-Cov-2 exposed anti-spike SARS-CoV-2 IgG 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. SARS-CoV-2 naive anti-spike SARS-CoV-2 IgG 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. Waiting list anti-spike SARS-CoV-2 IgG Kidney transplant recipients who were vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-Cov-2 exposed
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Graft function after vaccination 15 days-90 days Estimated glomerular filtration rate (eGFR)
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
Trial Locations
- Locations (1)
Institute for Clinical and Experimental Medicine
🇨🇿Prague, Czechia