VACCHEPA: Covid Vaccination in Liver Transplantation

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05079165

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

EVALUATION OF THE RESPONSE TO mRNA SARS-CoV-2 VACCINE IN A COHORT OF LIVER TRANSPLANTED OR LISTED PATIENTS

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Outcome Measures

Primary Outcome Measures

Retrospective description of the serological response to the anti-SARS-CoV-2 mRNA vaccine [Files analysed retrospectively from January 18, 2020 to April 30, 2021 will be examined]]