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Seroepidemiology of Viral Hepatitis in Hong Kong

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04371276
Collaborator
(none)
3,981
Enrollment
1
Location
49
Anticipated Duration (Months)
81.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

  1. 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
Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
3981 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
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
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. hepatitis B infection prevalence [12 months]

    Proportion of individuals with positive HBsAg

  2. hepatitis A immunity prevalence [12 months]

    Proportion of individuals with positive IgG against HAV

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prince of Wales Hospital Hong Kong Hong Kong China

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shui-Shan Lee, MD, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04371276
Other Study ID Numbers:
  • 17160962
First Posted:
May 1, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shui-Shan Lee, MD, Professor, Chinese University of Hong Kong
hepatitis A
hepatitis B
epidemiology
Additional relevant MeSH terms:
Hepatitis A
Hepatitis

Study Results

No Results Posted as of Mar 9, 2022