Clinical trial NCT04371276: Seroepidemiology of Viral Hepatitis in Hong Kong
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Hepatitis
Keywords: hepatitis A
hepatitis B
epidemiology
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 2888
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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 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


Eligibility criteria: 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

Primary outcomes:
measure: hepatitis B infection prevalence
timeFrame: 12 months
measure: hepatitis A immunity prevalence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Shui Shan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poon CM, Chan DP, Lee SS, Wong NS. Seroepidemiology of hepatitis A and B in the general population in Hong Kong: protocol of a cross-sectional survey using spatial sampling in a highly urbanised city. BMJ Open. 2021 Mar 22;11(3):e042065. doi: 10.1136/bmjopen-2020-042065.