Covid Vaccination in Liver Transplantation

NCT05079165 | Unknown

• 1 other identifier: 8261
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-COV-2; Coronavirus Vaccine; COVID-19 Pandemic; COVID-19 Virus Disease; SARS-CoV-2 Infection; Solid organ transplant; mRNA vaccine; MODERNA; liver transplant; Serological testing; serological response; SARS-CoV-2 mRNA vaccine; Anti-SARS-CoV-2 IgG antibodies

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver transplanted adult patients for \> 6 months after transplantation

You may qualify if:

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

You may not qualify if:

• Vaccination with non mRNA anti-SARS-CoV-2 vaccine
• Expressed opposition to participation to the study

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

François FAITOT, MD, PhD

CONTACT

33 3.88 12 72 85; francois.faitot@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 15, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: November 30, 2022
• Last Updated: February 3, 2022

Record last verified: 2021-10

Locations

FR (1)