Seroepidemiology of Viral Hepatitis in Hong Kong

February 6, 2023 updated by: Shui-Shan Lee, MD, Chinese University of Hong Kong

Evaluation of the Seroepidemiology of Hepatitis A and B in the General Population for Informing the Development of New Hepatitis Vaccination Strategies in Hong Kong

Immunisation policies have strong influences on the epidemiology of hepatitis A and B infection. In Hong Kong, vaccines against both viruses have been available through different channels and programmes in the past 3 decades. To evaluate the changes in the prevalence of hepatitis A and B in the general population, a seroepidemiology study is conducted involving a prospective cross-sectional survey followed for serology testing. Eligible members of 1327 spatially random households would be invited to join the study by completing a questionnaire and providing blood samples, either by dried blood spots or venesection, for determining the presence of antigen and/or antibody against hepatitis B, as well as antibody against hepatitis A. The main measures comprise a set of metrics on the prevalence of hepatitis A and B. Analysis would be conducted to examine the association of risk factors with the tested markers and describe the attitudes towards viral hepatitis vaccination. The results would allow us to understand the transmission potential of hepatitis A and B in the community would be influenced by the changing disease epidemiology and coverage of vaccination, which inform the development of new vaccination strategies in Hong Kong

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2888

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Residents of Building Groups from diverse geographical locations in Hong Kong selected through cluster sampling are targeted. With the building information available, three households would be randomly selected from each Building Group.

Description

Inclusion Criteria:

  • residents normally living in Hong Kong
  • living in domestic households randomly selected from Building Groups
  • Any age, while subjects below the age of 18 would require informed consent of their guardians for participation
  • Any gender

Exclusion Criteria:

  • unable to understand written Chinese or English,
  • failure to give consent for participation
  • living in institution or non-domestic housing,
  • foreign domestic helpers,
  • normally living in Hong Kong

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hepatitis B infection prevalence
Time Frame: 12 months
Proportion of individuals with positive HBsAg
12 months
hepatitis A immunity prevalence
Time Frame: 12 months
Proportion of individuals with positive IgG against HAV
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Shui Shan Lee, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

May 31, 2022

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (ACTUAL)

May 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17160962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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