NCT04832841

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 753 (actual)
• Sponsor: Institute for Clinical and Experimental Medicine · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	anti-spike SARS-CoV-2 IgG	Immunochemiluminescent assay by DiaSorin S.p.A. Italy

Timeline

• Start date: 2021-03-18
• Primary completion: 2021-09-30
• Completion: 2022-03-30
• First posted: 2021-04-06
• Last updated: 2024-03-06

Locations

1 site across 1 country: Czechia