Antibody Response to COVID-19 Vaccines in Liver Disease Patients

Humanity & Health Medical Group Limited

Status and phase: Completed; Phase 4

Conditions: Chronic Liver Disease

Treatments: Biological: BNT162b2; Biological: CoronaVac; Biological: AZD1222

Study type: Interventional

Funder types: Other

Identifiers

NCT04775069

HHCTC_COVID-19_VACCINE_Ab

Details and patient eligibility

About

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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 3 patient groups

mRNA Group

Active Comparator group

Description:

The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech).

Treatment:

Biological: BNT162b2

Inactivated Virus Group

Active Comparator group

Description:

The subjects will be vaccinated with inactivated SARS Cov-2 (Sinovac).

Treatment:

Biological: CoronaVac

Adenovirus-vector Group

Active Comparator group

Description:

The subjects will be vaccinated with adenovirus-vector COVID-19 vaccine (Astrazeneca-Oxford).

Treatment:

Biological: AZD1222