- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05271669
COVID-19 Immunity and Changes Over Time
Patterns of SARS-CoV-2 Immunity at Household Level and Their Changes Over Time
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Hong Kong
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Hong Kong, Hong Kong, China, 0000
- Recruiting
- Shui Shan Lee
-
Contact:
- Shui Shan Lee
- Phone Number: 085222528812
- Email: sslee.ss@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with COVID-19 protective immunity
Time Frame: 1 year
|
Prevalence of SARS-CoV-2 spike antibody
|
1 year
|
Proportion of participants with marker of past COVID-19 infection
Time Frame: 1 year
|
Prevalence of SARS-CoV-2 nucleocapsid antibody
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol HK COVID cohort 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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