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

Study Overview
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Brief Summary
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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
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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. .

Official Title
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Serological Responses to SARS-CoV-2 and Their Temporal Pattern in HIV Infected Persons

Conditions
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HIV Infections, SARS-CoV-2 Infection, Vaccination; Infection

Intervention / Treatment
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* Other: blood sampling


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: unable to communicate in written/spoken Chinese or English concurrent mental illnesses prisoners absence of consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV positive<br>No interventions | Other: blood sampling<br>* blood sampling for determining antibody responses<br>|
| HIV uninfected<br>No interventions | Other: blood sampling<br>* blood sampling for determining antibody responses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 antibody early response to infection | proportion antibody positive within 3 months of infection | 3 months | 
| SARS-CoV-2 antibody early response to vaccination | proportion antibody positive within 3 months of vaccination | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 sustained post-infection antibody response | proportion antibody positive at one year after infection | 1 year | 
| SARS-CoV-2 sustained vaccination response | proportion antibody positive at one year after vaccination | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, COVID-19, SARS-CoV-2 vaccination, co-infection, antibody responses