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NCT05028881 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05028881
Other study ID # Protocol HIV_COVID-19
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 16, 2020
Est. completion date November 2024

Study information
Verified date August 2023
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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. .

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 800
Est. completion date November 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• blood sampling
blood sampling for determining antibody responses

Locations
Country Name City State
China Shui Shan Lee Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary SARS-CoV-2 antibody early response to infection proportion antibody positive within 3 months of infection 3 months
Primary SARS-CoV-2 antibody early response to vaccination proportion antibody positive within 3 months of vaccination 3 months
Secondary SARS-CoV-2 sustained post-infection antibody response proportion antibody positive at one year after infection 1 year
Secondary SARS-CoV-2 sustained vaccination response proportion antibody positive at one year after vaccination 1 year
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