Antibody Response to COVID-19 Vaccines in Liver Disease Patients
Primary Purpose
Chronic Liver Disease
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
BNT162b2
CoronaVac
AZD1222
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Liver Disease
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.
Sites / Locations
- Humanity & Health Medical Group Limited
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
mRNA Group
Inactivated Virus Group
Adenovirus-vector Group
Arm Description
The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech).
The subjects will be vaccinated with inactivated SARS Cov-2 (Sinovac).
The subjects will be vaccinated with adenovirus-vector COVID-19 vaccine (Astrazeneca-Oxford).
Outcomes
Primary Outcome Measures
Antibody response
Covid-19 Antibodies IgG titres at 4 weeks after second dose
Secondary Outcome Measures
Antibody response
Covid-19 Antibodies IgG titres at one year after second dose
Full Information
NCT ID
NCT04775069
First Posted
February 24, 2021
Last Updated
October 2, 2023
Sponsor
Humanity & Health Medical Group Limited
1. Study Identification
Unique Protocol Identification Number
NCT04775069
Brief Title
Antibody Response to COVID-19 Vaccines in Liver Disease Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanity & Health Medical Group Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mRNA Group
Arm Type
Active Comparator
Arm Description
The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech).
Arm Title
Inactivated Virus Group
Arm Type
Active Comparator
Arm Description
The subjects will be vaccinated with inactivated SARS Cov-2 (Sinovac).
Arm Title
Adenovirus-vector Group
Arm Type
Active Comparator
Arm Description
The subjects will be vaccinated with adenovirus-vector COVID-19 vaccine (Astrazeneca-Oxford).
Intervention Type
Biological
Intervention Name(s)
BNT162b2
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
CoronaVac
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
AZD1222
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Antibody response
Description
Covid-19 Antibodies IgG titres at 4 weeks after second dose
Time Frame
at 4 weeks after second dose
Secondary Outcome Measure Information:
Title
Antibody response
Description
Covid-19 Antibodies IgG titres at one year after second dose
Time Frame
at one year after second dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Humanity & Health Medical Group Limited
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33577086
Citation
Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751.
Results Reference
background
PubMed Identifier
32785213
Citation
Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Tureci O, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Sahin U, Jansen KU. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020 Oct;586(7830):589-593. doi: 10.1038/s41586-020-2639-4. Epub 2020 Aug 12. Erratum In: Nature. 2021 Feb;590(7844):E26.
Results Reference
background
PubMed Identifier
33217362
Citation
Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.
Results Reference
background
PubMed Identifier
32702298
Citation
Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20. Erratum In: Lancet. 2020 Aug 15;396(10249):466. Lancet. 2020 Dec 12;396(10266):1884.
Results Reference
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Antibody Response to COVID-19 Vaccines in Liver Disease Patients
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