Antibody Response to COVID-19 Vaccines in Liver Disease Patients

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Liver Disease

Intervention / Treatment
-----------------
* Biological: BNT162b2
* Biological: CoronaVac
* Biological: AZD1222


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mRNA Group<br>The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech). | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Active Comparator: Inactivated Virus Group<br>The subjects will be vaccinated with inactivated SARS Cov-2 (Sinovac). | Biological: CoronaVac<br>* Intramuscular injection<br>|
| Active Comparator: Adenovirus-vector Group<br>The subjects will be vaccinated with adenovirus-vector COVID-19 vaccine (Astrazeneca-Oxford). | Biological: AZD1222<br>* Intramuscular injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response | Covid-19 Antibodies IgG titres at 4 weeks after second dose | at 4 weeks after second dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response | Covid-19 Antibodies IgG titres at one year after second dose | at one year after second dose |