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

Institute for Clinical and Experimental Medicine

Status: Completed

Conditions: Kidney Transplantation

Treatments: Diagnostic Test: anti-spike SARS-CoV-2 IgG

Study type: Observational

Funder types: Other

Identifiers

NCT04832841

G-21-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 753 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

753 participants in 3 patient groups

SARS-CoV-2 naive

Description:

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.

Treatment:

Diagnostic Test: anti-spike SARS-CoV-2 IgG

SARS-Cov-2 exposed

Description:

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.

Treatment:

Diagnostic Test: anti-spike SARS-CoV-2 IgG

Waiting list

Description:

Kidney transplant recipients who were vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-Cov-2 exposed

Treatment:

Diagnostic Test: anti-spike SARS-CoV-2 IgG