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临床试验/NCT04371276
NCT04371276已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 2,888 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,888
试验地点
1
主要终点
hepatitis A immunity prevalence

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

hepatitis A immunity prevalence

时间窗: 12 months

Proportion of individuals with positive IgG against HAV

hepatitis B infection prevalence

时间窗: 12 months

Proportion of individuals with positive HBsAg

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shui-Shan Lee, MD

Professor

Chinese University of Hong Kong

研究点 (1)

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