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

The HEPCOViVac Registry - Immunological response in patients with liver disease vaccinated against COVID-19

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001103-32-AT

Enrollment

500

Registered

2021-04-08

Start date

2021-04-26

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

Cirrhotic chronic liver disease

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Concentrate for suspension for injection INN or Proposed INN: Comirnaty Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactLiver Clinic

Medical University of Graz

rudolf.stauber@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026