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Clinical Trials/NCT05271669
NCT05271669RecruitingNot Applicable

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

Chinese University of Hong Kong1 site in 1 country1,350 target enrollmentStarted: June 6, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,350
Locations
1
Primary Endpoint
Proportion of participants with COVID-19 protective immunity

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • individuals with mental illness
  • prisoners

Outcomes

Primary Outcomes

Proportion of participants with COVID-19 protective immunity

Time Frame: 1 year

Prevalence of SARS-CoV-2 spike antibody

Proportion of participants with marker of past COVID-19 infection

Time Frame: 1 year

Prevalence of SARS-CoV-2 nucleocapsid antibody

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shui-Shan Lee, MD

Research Professor

Chinese University of Hong Kong

Study Sites (1)

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