Antibody Response to COVID-19 Vaccines in Liver Disease Patients

NCT ID: NCT04775069

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Chronic Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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mRNA Group

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

Group Type ACTIVE_COMPARATOR

BNT162b2

Intervention Type BIOLOGICAL

Intramuscular injection

Inactivated Virus Group

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

Group Type ACTIVE_COMPARATOR

CoronaVac

Intervention Type BIOLOGICAL

Intramuscular injection

Adenovirus-vector Group

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

Group Type ACTIVE_COMPARATOR

AZD1222

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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BNT162b2

Intramuscular injection

Intervention Type BIOLOGICAL

CoronaVac

Intramuscular injection

Intervention Type BIOLOGICAL

AZD1222

Intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanity & Health Medical Group Limited

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanity & Health Medical Group Limited

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type BACKGROUND
PMID: 33577086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32785213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33217362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32702298 (View on PubMed)

Other Identifiers

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HHCTC_COVID-19_VACCINE_Ab

Identifier Type: -

Identifier Source: org_study_id

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