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OpenTrials
Completed

NCT Number: NCT04775069

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.

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Key information

Conditions

Chronic Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Humanity & Health Medical Group Limited

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with chronic liver disease (CLD) at the Humanity and Health Medical Group and eligible for the HK government vaccination programme;
  • Able to understand and sign informed consent.;
  • 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

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

Treatment and study plan

BNT162b2

Biological

Intramuscular injection

CoronaVac

Biological

Intramuscular injection

AZD1222

Biological

Intramuscular injection

Primary outcomes

  1. Antibody response

    Time frame: at 4 weeks after second dose

    Covid-19 Antibodies IgG titres at 4 weeks after second dose

Secondary outcomes

  1. Antibody response

    Time frame: at one year after second dose

    Covid-19 Antibodies IgG titres at one year after second dose

Sponsors and collaborators

Lead sponsor

Humanity & Health Medical Group Limited

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2021
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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