Antibody Response to COVID-19 Vaccines in Liver Disease Patients

Phase 4

Completed

• Conditions: Chronic Liver Disease
• Interventions: Biological: BNT162b2; Biological: CoronaVac; Biological: AZD1222

• Registration Number: NCT04775069
• Lead Sponsor: Humanity & Health Medical Group Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2021-05-21
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mRNA Group	BNT162b2	The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech).
Inactivated Virus Group	CoronaVac	The subjects will be vaccinated with inactivated SARS Cov-2 (Sinovac).
Adenovirus-vector Group	AZD1222	The subjects will be vaccinated with adenovirus-vector COVID-19 vaccine (Astrazeneca-Oxford).

Primary Outcome Measures

Name	Time	Method
Antibody response	at 4 weeks after second dose	Covid-19 Antibodies IgG titres at 4 weeks after second dose

Secondary Outcome Measures

Name	Time	Method
Antibody response	at one year after second dose	Covid-19 Antibodies IgG titres at one year after second dose

Trial Locations

Locations (1)

Humanity & Health Medical Group Limited; 🇭🇰 Hong Kong, Hong Kong