Covid Vaccination in Liver Transplantation

NCT ID: NCT05079165

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-11-30

Brief Summary

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The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients.

Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19.

The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination.

Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria.

The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population.

The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion.

A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis.

Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Liver transplanted patients for \> 6 months after transplantation
* Listed cirrhotic patients
* Age \>18 years-old
* Consent for vaccination with mRNA vaccine

Exclusion Criteria

* Vaccination with non mRNA anti-SARS-CoV-2 vaccine
* Expressed opposition to participation to the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service deChirurgie Générale Hépatique-Endocrinienne,et transplantation - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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François FAITOT, MD, PhD

Role: CONTACT

33 3.88 12 72 85

Saïd CHAYER, PhD, HDR

Role: CONTACT

Facility Contacts

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François FAITOT, MD, PhD

Role: primary

33 3.88 12 72 85

Saïd CHAYER, PhD, HDR

Role: backup

Other Identifiers

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8261

Identifier Type: -

Identifier Source: org_study_id

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