Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.

March 5, 2024 updated by: Prof. Ondřej Viklický, M.D., Ph.D., Institute for Clinical and Experimental Medicine

Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.

Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia, 14021
        • Institute for Clinical and Experimental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients, vaccinated with 2 doses of mRNA vaccines against COVID, scheduled for the first booster dose.

Description

Inclusion Criteria:

  • Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM)
  • vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273)
  • immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil
  • COVID naive

Exclusion Criteria:

  • age < 18 years
  • pregnant women, breastfeeding women
  • unable/unwilling to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First booster dose group
Biological: Booster dose of mRNA vaccine
Administration of SARS-CoV-2 mRNA vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological safety - anti-HLA antibodies
Time Frame: Comparison of anti-HLA single antigen bead assays at booster dose and three months later.
Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level.
Comparison of anti-HLA single antigen bead assays at booster dose and three months later.
Immunological safety - donor-derived cell-free DNA
Time Frame: Comparison of dd-cfDNA assays at booster dose and three months later.
Elevation of dd-cfDNA above 1% threshold
Comparison of dd-cfDNA assays at booster dose and three months later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological effectiveness - anti-SARS-CoV-2 antibodies
Time Frame: Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.
Emergence or increase of anti-SARS-CoV-2 IgG.
Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Investigators

  • Principal Investigator: Ondrej Viklicky, MD, PhD, Head of Department of Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Estimated)

December 4, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-21-71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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