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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

753 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-18

Study Completion Date

2022-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

anti-spike SARS-CoV-2 IgG

Intervention Type DIAGNOSTIC_TEST

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.

anti-spike SARS-CoV-2 IgG

Intervention Type DIAGNOSTIC_TEST

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

anti-spike SARS-CoV-2 IgG

Intervention Type DIAGNOSTIC_TEST

Immunochemiluminescent assay by DiaSorin S.p.A. Italy

Interventions

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anti-spike SARS-CoV-2 IgG

Immunochemiluminescent assay by DiaSorin S.p.A. Italy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No