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Antibody Response to COVID-19 Vaccines in Liver Disease Patients

A Prospective Study Comparing the Antibody Response of Subjects With Chronic Liver Disease to mRNA, Inactivated Virus and Adenovirus Vector COVID-19 Vaccines

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04775069
Enrollment
232
Registered
2021-03-01
Start date
2021-05-21
Completion date
2023-09-30
Last updated
2023-10-04

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

Conditions

Chronic Liver Disease

Brief summary

Currently the Pfizer-Biontech (mRNA), Sinovac (inactivated virus) and Astrazeneca-Oxford (adenovirus-vector) COVID-19 vaccines are available for vaccination in HK. The American Association of Liver Disease has recently published consensus statements for COVID-19 vaccination in subjects with chronic liver disease (CLD). Patients with CLD have dysregulated innate and adaptive immune response that may be associated with vaccine hypo-responsiveness and there are no data as to whether these patients may respond differently to the various vaccines. The Humanity and Health Medical Center (HHMC) is an active participant of the HK government COVID-19 vaccination programs and patients with CLD follow-up at HHMC will have access to the three different vaccines. The aim of this prospective study is to compare the antibody response of CLD subjects to the Pfizer-Biontech (mRNA), Sinovac (inactivated virus) and Astrazeneca-Oxford (adenovirus-vector) COVID-19 vaccines.

Interventions

BIOLOGICALBNT162b2

Intramuscular injection

BIOLOGICALCoronaVac

Intramuscular injection

BIOLOGICALAZD1222

Intramuscular injection

Sponsors

Humanity & Health Medical Group Limited
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Subjects with chronic liver disease (CLD) at the Humanity and Health Medical Group and eligible for the HK government vaccination programme; 2. Able to understand and sign informed consent.; 3. Underlying CLD- defined as patients with chronic hepatitis B or C infections, liver cirrhosis, metabolic associated liver disease, hepatocellular carcinoma, alcoholic liver disease, autoimmune hepatitis, hemochrombtosis.

Exclusion criteria

1. Patients contraindicated for the COVID -19 Vaccination Program due to uncontrolled co-morbitities; 2. Past allergies to other vaccines; 3. Pregnant subjects.

Design outcomes

Primary

MeasureTime frameDescription
Antibody responseat 4 weeks after second doseCovid-19 Antibodies IgG titres at 4 weeks after second dose

Secondary

MeasureTime frameDescription
Antibody responseat one year after second doseCovid-19 Antibodies IgG titres at one year after second dose

Countries

Hong Kong

Outcome results

None listed

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