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

March 5, 2024 updated by: Prof. Ondřej Viklický, M.D., Ph.D., Institute for Clinical and Experimental Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

753

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 140 21
        • Institute for Clinical and Experimental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Kidney transplant recipients vaccinated with 2 doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: anti-spike SARS-CoV-2 IgG
Immunochemiluminescent assay by DiaSorin S.p.A. Italy
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.
Diagnostic test: anti-spike SARS-CoV-2 IgG
Immunochemiluminescent assay by DiaSorin S.p.A. Italy
Waiting list
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
Immunochemiluminescent assay by DiaSorin S.p.A. Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
Time Frame: 15 days-90 days
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.
Time Frame: 3 months - 6 months
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.
Time Frame: 15 - 90 days
Cellular immunity measured by ELISPOT assay in subgroup of 50 patients
15 - 90 days
Graft function after vaccination
Time Frame: 15 days-90 days
Estimated glomerular filtration rate (eGFR)
15 days-90 days
Clinical variables affecting antibody levels
Time Frame: 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).
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
Time Frame: 15 days-90 days
Fried frailty score
15 days-90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Investigators

  • Principal Investigator: Ondrej Viklicky, Prof., Institute for Clinical and Experimental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

April 3, 2021

First Submitted That Met QC Criteria

April 3, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • G-21-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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