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Seroepidemiology of Viral Hepatitis in Hong Kong

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371276
Recruitment Status : Enrolling by invitation
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Shui-Shan Lee, MD, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment
Viral Hepatitis Other: No intervention

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Study Type : Observational
Estimated 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 : September 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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)
    Other Name: blood sampling for serology testing


Primary Outcome Measures :
  1. hepatitis B infection prevalence [ Time Frame: 12 months ]
    Proportion of individuals with positive HBsAg

  2. hepatitis A immunity prevalence [ Time Frame: 12 months ]
    Proportion of individuals with positive IgG against HAV


Biospecimen Retention:   Samples Without DNA
blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

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): NCT04371276


Locations
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China, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Shui Shan Lee, MD Chinese University of Hong Kong
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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    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
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
Keywords provided by Shui-Shan Lee, MD, Chinese University of Hong Kong:
hepatitis A
hepatitis B
epidemiology
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections