Response of the immune system to Covid-19 vaccination in liver disease

Phase 1

• Conditions: Cirrhotic chronic liver disease; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-001103-32-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

chronic liver disease of any etiology
age above 18 years
signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

allergy to any excipient of the vaccine
pregnancy
expected survival <3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the immune response to Covid-19 vaccination with a licensed vaccine in chronic liver disease;Secondary Objective: To compare the efficacy of Covid-19 vaccination in patients with chronic liver disease versus healthy individuals;Primary end point(s): plasma concentration of neutralizing SARS-CoV-2 antibodies;Timepoint(s) of evaluation of this end point: baseline, 2 weeks after first vaccination, 2 weeks after second vaccination, month 6, month 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): incidence of Covid-19 infection in study participants ;Timepoint(s) of evaluation of this end point: baseline, 2 weeks after first vaccination, 2 weeks after second vaccination, month 6, month 12