COVID-19 Serology in People Living with HIV in Hong Kong
NCT ID: NCT05028881
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
488 participants
OBSERVATIONAL
2020-05-16
2024-11-15
Brief Summary
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Detailed Description
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This is a descriptive study involving the analyses of data derived from the testing of PLHA and non-infected controls at different time-points, following SARS-CoV-2 infection / COVID-19 or vaccination, in conjunction with routinely collected clinical data in the setting of Hong Kong.
The total number of subjects to be recruited is 800, of which 50 would be HIV/SARS-CoV-2 co-infected persons. In order that their serological responses to SARS-CoV-2 could be interpreted in perspective, 400 HIV uninfected adults would be recruited for comparison. Separately, 400 PLHA and 50 healthy adults who have received SARS-CoV-2 vaccination would be recruited to form another control group.
Blood sampling would be performed upon diagnosis of COVID-19 disease when a SARS-CoV-2 infected person is hospitalized for treatment, or after vaccination. This would be repeated after discharge for hospitalized patients and on follow-up at the following time-points: 3, 6, 12, 18 and 24 months. Plasma would be separated from the collected blood samples and stored at -20°C before testing. The levels of antibody to SARS-CoV-2 nucleocapsid and spike protein would be measured using enzyme linked immunosorbent assay (ELISA) method, while surrogate virus neutralization test (sVNT) would be performed to track the changes of sero-protection. .
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIV positive
No interventions
blood sampling
blood sampling for determining antibody responses
HIV uninfected
No interventions
blood sampling
blood sampling for determining antibody responses
Interventions
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blood sampling
blood sampling for determining antibody responses
Eligibility Criteria
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Inclusion Criteria
* known HIV status
* infection with SARS-CoV-2 or completion of vaccination against SARS-CoV-2
Exclusion Criteria
* concurrent mental illnesses
* prisoners
* absence of consent
18 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Shui-Shan Lee, MD
Research Professor
Principal Investigators
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Shui Shan Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Shui Shan Lee
Hong Kong, Hong Kong, China
Countries
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Other Identifiers
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Protocol HIV_COVID-19
Identifier Type: -
Identifier Source: org_study_id
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