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Covid Vaccination in Liver Transplantation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05079165
Acronym
VACCHEPA
Enrollment
300
Registered
2021-10-15
Start date
2021-06-01
Completion date
2022-11-30
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactFrançois FAITOT, MD, PhD
francois.faitot@chru-strasbourg.fr33 3.88 12 72 85
Backup ContactSaïd CHAYER, PhD, HDR
said.chayer@chru-strasbourg.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026