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临床试验/NCT05271669
NCT05271669招募中不适用

Patterns of SARS-CoV-2 Immunity at Household Level and Their Changes Over Time

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,350 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,350
试验地点
1
主要终点
Proportion of participants with COVID-19 protective immunity

研究概览

简要总结

The risk of household spread of SARS-CoV-2 hinges on both the transmission dynamics of the virus circulating in the community as well as the seroprotection pattern of constituent members, which can be attributed to vaccination and previous infections. This study is conceptualised to assess the dynamicity of SARS-CoV-2 risk at the household level, through monitoring the pattern of seroprotection, in conjunction with the vaccination coverage, history of infection and exposure risk in the setting of Hong Kong.

详细描述

The aim of this study is to assess the SARS-CoV-2 risk at the household level, with the objectives of (a) determining the coverage of vaccination and its changes over time; (b) monitoring pattern of exposure and history of infection; and (c) evaluating the level of seroprotection and its longitudinal trend.

A cohort of households comprising 900 persons would be recruited. Invited participants would be attend the Research Centre for blood sampling and the completion of a simple questionnaire at 3 different timepoints at 12-18 months apart. A questionnaire would be administered to capture the following characteristics: (a) Socio-demographics; (b) History of SARS-CoV-2 infection; (c) adoption of precautionary measures; (d) SARS-CoV-2 testing history and (e) SARS-CoV-2 vaccination uptake.

Participants would be tested for SARS-CoV-2 serology. The main markers for measurement are nucleocapsid antibody for inferring past infection, spike antibody for the immunological responses, and seroprotection by SARS-CoV-2 surrogate virus neutralisation test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • adults of age 18 or above, or children under the age of 18 with informed consent of the legal guardian
  • normally residing in Hong Kong
  • could communicate in spoken and written Chinese and/or English

排除标准

  • individuals with mental illness
  • prisoners

结局指标

主要结局

Proportion of participants with COVID-19 protective immunity

时间窗: 1 year

Prevalence of SARS-CoV-2 spike antibody

Proportion of participants with marker of past COVID-19 infection

时间窗: 1 year

Prevalence of SARS-CoV-2 nucleocapsid antibody

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

Research Professor

Chinese University of Hong Kong

研究点 (1)

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