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Antibody Response to COVID-19 Vaccines in Liver Disease Patients

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ClinicalTrials.gov Identifier: NCT04775069
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Humanity & Health Medical Group Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Liver Disease Biological: BNT162b2 Biological: CoronaVac Biological: AZD1222 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : May 21, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: mRNA Group
The subjects will be vaccinated with the mRNA vaccine (Pfizer-Biontech).
 Biological: BNT162b2
Intramuscular injection
Active Comparator: Inactivated Virus Group
The subjects will be vaccinated with inactivated SARS Cov-2 (Sinovac).
 Biological: CoronaVac
Intramuscular injection
Active Comparator: Adenovirus-vector Group
The subjects will be vaccinated with adenovirus-vector COVID-19 vaccine (Astrazeneca-Oxford).
 Biological: AZD1222
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. Antibody response [ Time Frame: at 4 weeks after second dose ]
    Covid-19 Antibodies IgG titres at 4 weeks after second dose


Secondary Outcome Measures :
  1. Antibody response [ Time Frame: at one year after second dose ]
    Covid-19 Antibodies IgG titres at one year after second dose


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775069


Locations
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Hong Kong
Humanity & Health Medical Group Limited Recruiting
Hong Kong, Hong Kong
Contact: George Lau, MD    852-28613777    info@hnhmgl.com   
Sponsors and Collaborators
Humanity & Health Medical Group Limited
More Information
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Publications:

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Responsible Party: Humanity & Health Medical Group Limited
ClinicalTrials.gov Identifier: NCT04775069    
Other Study ID Numbers: HHCTC_COVID-19_VACCINE_Ab
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases