Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients (COVATRHUS)

August 18, 2025 updated by: University Hospital, Strasbourg, France

Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients

The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2.

The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. These patients will be vaccinated as part of routine care with a CoV-2 SARS vaccine licensed in France.

In this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against SARS CoV-2 and the specific cellular response of SARS Cov-2 by quantiferon and in vitro lymphocyte stimulation assays.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

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

  • France
      • Strasbourg, France, 67000
        • Caillard Sophie

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

No

Sampling Method

Non-Probability Sample

Study Population

kidney transplants

Description

Inclusion Criteria:

  • Male or female, 18 years of age or older
  • Patient vaccinated against SARS-CoV-2 as part of routine care
  • Kidney or pancreatic kidney transplant
  • Transplantation for more than 3 months
  • Subject affiliated to a social protection health insurance
  • Subject able to understand the objectives and risks of the research and to give signed and dated informed consent

Exclusion Criteria:

  • History of anaphylactic shock or known allergy to PEG
  • Known history of COVID or positive Covid serology in the 3 months prior to vaccination
  • Contraindication to an intramuscular injection
  • Impossibility to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject, ...)
  • Subject under safeguard of justice
  • Subject under guardianship

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time Frame: Month 1 after vaccination
Month 1 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time Frame: Month 3 after vaccination
Month 3 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time Frame: Month 6 after vaccination
Month 6 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time Frame: Month 12 after vaccination
Month 12 after vaccination
The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.
Time Frame: Month 24 after vaccination
Month 24 after vaccination

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

February 2, 2021

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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