Clinical trial NCT04832841: IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation (TASMANIA)
Official title: IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: kidney transplantation
SARS-CoV-2
humoral immunity
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2021-04-06
Enrollment: 753
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
timeFrame: 15 days-90 days
Secondary outcomes:
measure: Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
timeFrame: 3 months - 6 months
measure: Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
timeFrame: 15 - 90 days
measure: Graft function after vaccination
timeFrame: 15 days-90 days
measure: Clinical variables affecting antibody levels
timeFrame: 15 days-90 days
measure: The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination
timeFrame: 15 days-90 days
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Ondrej Viklicky, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magicova M, Zahradka I, Fialova M, Neskudla T, Gurka J, Modos I, Hojny M, Raska P, Smejkal P, Striz I, Viklicky O. Determinants of Immune Response to Anti-SARS-CoV-2 mRNA Vaccines in Kidney Transplant Recipients: A Prospective Cohort Study. Transplantation. 2022 Apr 1;106(4):842-852. doi: 10.1097/TP.0000000000004044.