Seroepidemiology of Viral Hepatitis in Hong Kong

Viral Hepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371276
• Other study ID #: 17160962
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2888
• Est. completion date: May 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Viral Hepatitis

Intervention

Other:
• No intervention
Blood samples will be collected from recruited subjects from invited households for testing for hepatitis B (HBsAg, anti-HBs and anti-HBc) and hepatitis A (anti-HAV)

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatitis B infection prevalence	Proportion of individuals with positive HBsAg	12 months
Primary	hepatitis A immunity prevalence	Proportion of individuals with positive IgG against HAV	12 months