Clincosm LogoSign in Get a demo

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

Sponsor
Institute for Clinical and Experimental Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04832841
Collaborator
(none)
753
Enrollment
1
Location
9.4
Anticipated Duration (Months)
79.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: anti-spike SARS-CoV-2 IgG

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 Design

Study Type:
Observational
Actual Enrollment :
753 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation
Actual Study Start Date :
Mar 18, 2021
Actual Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. [15 days-90 days]

    anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination

Secondary Outcome Measures

  1. Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. [3 months - 6 months]

    anti-spike SARS-CoV-2 IgG measured 3 ≥ months after the first blood sampling

  2. Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. [15 - 90 days]

    Cellular immunity measured by ELISPOT assay in subgroup of 50 patients

  3. Graft function after vaccination [15 days-90 days]

    Estimated glomerular filtration rate (eGFR)

  4. Clinical variables affecting antibody levels [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).

  5. The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination [15 days-90 days]

    Fried frailty score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute for Clinical and Experimental Medicine Prague Czechia 140 21

Sponsors and Collaborators

  • Institute for Clinical and Experimental Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Ondřej Viklický, M.D., Ph.D., Head of Department of Nephrology and Transplant Center, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT04832841
Other Study ID Numbers:
  • G-21-07
First Posted:
Apr 6, 2021
Last Update Posted:
Jan 6, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Ondřej Viklický, M.D., Ph.D., Head of Department of Nephrology and Transplant Center, Institute for Clinical and Experimental Medicine
kidney transplantation
SARS-CoV-2
humoral immunity

Study Results

No Results Posted as of Jan 6, 2022