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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; SARS-CoV-2 Infection; Vaccination; Infection
• Intervention / Treatment: Other: blood sampling

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 Type: Observational
• Enrollment (Actual): 488

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China, 0000
      • Shui Shan Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People living with HIV and HIV uninfected persons who have been diagnosed with SARS-CoV-2 infection or have received vaccination against the virus.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV positive; No interventions	Other: blood sampling; blood sampling for determining antibody responses
HIV uninfected; No interventions	Other: blood sampling; blood sampling for determining antibody responses

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Shui Shan Lee, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2020
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: August 28, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: HIV; COVID-19; co-infection; SARS-CoV-2 vaccination; antibody responses
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: Protocol HIV_COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data are kept in confidence and would not be available to researchers outside the study, as has been bound by ethics approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No