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NCT04832841 Clinical Trial

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

Kidney Transplantation Clinical Trial

— TASMANIA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04832841
Other study ID # G-21-07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 18, 2021
Est. completion date March 30, 2022

Study information
Verified date March 2024
Source Institute for Clinical and Experimental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 753
Est. completion date March 30, 2022
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• anti-spike SARS-CoV-2 IgG
Immunochemiluminescent assay by DiaSorin S.p.A. Italy

Locations
Country Name City State
Czechia Institute for Clinical and Experimental Medicine Prague

Sponsors (1)
Lead Sponsor Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Graft function after vaccination Estimated glomerular filtration rate (eGFR) 15 days-90 days
Secondary 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
Secondary 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
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