NCT04832841

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
753

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

April 3, 2021

Last Update Submit

March 5, 2024

Conditions

Kidney Transplantation

Keywords

kidney transplantationSARS-CoV-2humoral immunity

Outcome Measures

Primary Outcomes (1)

  • Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.

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

    15 days-90 days

Secondary Outcomes (5)

  • Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.

    3 months - 6 months

  • Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.

    15 - 90 days

  • Graft function after vaccination

    15 days-90 days

  • Clinical variables affecting antibody levels

    15 days-90 days

  • 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

Study Arms (3)

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

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

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

Interventions

anti-spike SARS-CoV-2 IgGDIAGNOSTIC_TEST

Immunochemiluminescent assay by DiaSorin S.p.A. Italy

SARS-CoV-2 naiveSARS-Cov-2 exposedWaiting list

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Kidney transplant recipients vaccinated with 2 doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

Related Publications (2)

  • Schmalz M, Vankova H, Rajnochova-Bloudickova S, Hruba P, Fialova M, Gurka J, Magicova M, Striz I, Zahradka I, Viklicky O. The impact of frailty syndrome on humoral response to SARS-CoV-2 mRNA vaccines in older kidney transplant recipients. Int Urol Nephrol. 2023 Nov;55(11):2959-2965. doi: 10.1007/s11255-023-03557-6. Epub 2023 Apr 7.

    PMID: 37027078DERIVED

  • 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.

    PMID: 34999659DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

Study Officials

  • Ondrej Viklicky, Prof.

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Nephrology and Transplant Center

Study Record Dates

First Submitted

April 3, 2021

First Posted

April 6, 2021

Study Start

March 18, 2021

Primary Completion

September 30, 2021

Study Completion

March 30, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

CZ(1)