Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients (COVATRANS)

November 4, 2021 updated by: University Hospital, Strasbourg, France

Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.

It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.

Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

3500

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kidney transplant recipients followed in French transplant centers

Description

Inclusion Criteria:

  • Patient, male or female, adult or child (15 years and older)
  • Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the 2 injections
  • Solid organ transplant recipient
  • Transplantation for more than 3 months

Exclusion Criteria:

  • History of anaphylactic shock or known allergy to PEG
  • Known history of COVID or positive Covid serology in the 3 months preceding inclusion
  • Formal contraindication to an intra-muscular injection
  • Impossibility to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
  • Subject under legal protection
  • Subject under guardianship or curatorship
  • Patient having expressed his opposition to participate

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

Cohorts and Interventions

Group / Cohort
Kidney transplant recipients who receive Covid-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Time Frame: One month after the 2nd injection of the COVID-19 vaccine
One month after the 2nd injection of the COVID-19 vaccine

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the seroconversion between different vaccines
Time Frame: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Time Frame: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.
Describe the patients characteristics associated with seroconversion
Time Frame: At Month 24 after the 2nd injection of the COVID-19 vaccine
At Month 24 after the 2nd injection of the COVID-19 vaccine
Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients
Time Frame: At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies
Time Frame: At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies

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 9, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8133

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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