Antibody Response to COVID-19 Vaccines in Liver Disease Patients


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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021


  • Biological: BNT162b2
    • Intramuscular injection
  • Biological: CoronaVac
    • Intramuscular injection
  • Biological: AZD1222
    • Intramuscular injection

Arms, Groups and Cohorts

  • Active Comparator: mRNA Group
    • The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech).
  • Active Comparator: Inactivated Virus Group
    • The subjects will be vaccinated with inactivated SARS Cov-2 (Sinovac).
  • Active Comparator: Adenovirus-vector Group
    • The subjects will be vaccinated with adenovirus-vector COVID-19 vaccine (Astrazeneca-Oxford).

Clinical Trial Outcome Measures

Primary Measures

  • Antibody response
    • Time Frame: at 4 weeks after second dose
    • Covid-19 Antibodies IgG titres at 4 weeks after second dose

Secondary Measures

  • Antibody response
    • Time Frame: at one year after second dose
    • Covid-19 Antibodies IgG titres at one year after second dose

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Humanity & Health Medical Group Limited
  • Provider of Information About this Clinical Study
    • Sponsor


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