COVID-19 Serology in People Living With HIV in Hong Kong

• Conditions: Vaccination; Infection; HIV Infections; SARS-CoV-2 Infection
• Interventions: Other: blood sampling

• Registration Number: NCT05028881
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Immunodeficiency associated with human immunodeficiency virus (HIV) infection could predispose people living with HIV/AIDS (PLHA) to defective serological responses following infection or vaccination. To evaluate the health outcomes of coronovirus disease-2019 (COVID-19) and HIV co-infection, PLHA and HIV-uninfected persons in Hong Kong are invited to join a study for understanding their clinical characteristics and for tracking their levels of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) over a one-year observation period after infection or vaccination. The results could inform the development of prevention and control strategy for PLHA in response to the emerging coronavirus threats.

Detailed Description

The aim of the study is to evaluate the health outcomes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) co-infection in people living with HIV/AIDS (PLHA) in Hong Kong, with the specific objectives of (a) describing the clinical and immunological characteristics of coronavirus diseases-2019 (COVID-19) in PLHA; (b) tracking the CD (cluster of differentiation) 4/CD8 lymphocytes changes following SARS-CoV-2 infection; (c) assessing the temporal changes of SARS-CoV-2 serology profile of PLHA following SARS-CoV-2 transmission and vaccination.

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. .

Study Timeline

• Study Start: 2020-05-16
• Study First Submitted: 2021-08-28
• Study First Submitted QC: 2021-08-28
• Study First Posted: 2021-08-31
• Primary Completion: 2024-05-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• adults of age 18 or above, with
• known HIV status
• infection with SARS-CoV-2 or completion of vaccination against SARS-CoV-2

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Exclusion Criteria

• unable to communicate in written/spoken Chinese or English
• concurrent mental illnesses
• prisoners
• absence of consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV positive	blood sampling	No interventions
HIV uninfected	blood sampling	No interventions

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 antibody early response to infection	3 months	proportion antibody positive within 3 months of infection
SARS-CoV-2 antibody early response to vaccination	3 months	proportion antibody positive within 3 months of vaccination

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 sustained post-infection antibody response	1 year	proportion antibody positive at one year after infection
SARS-CoV-2 sustained vaccination response	1 year	proportion antibody positive at one year after vaccination

Trial Locations

Locations (1)

Shui Shan Lee; 🇨🇳 Hong Kong, Hong Kong, China