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NCT Number: NCT05028881

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections COVID-19 Coinfection Communicable Diseases Coronaviridae Infections Coronavirus Infections Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sars-CoV-2 Infection Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vaccination; Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shui Shan Lee

Hong Kong, 0000, China

About this study

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. .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

blood sampling for determining antibody responses

Primary outcomes

  1. SARS-CoV-2 antibody early response to infection

    Time frame: 3 months

    proportion antibody positive within 3 months of infection

  2. SARS-CoV-2 antibody early response to vaccination

    Time frame: 3 months

    proportion antibody positive within 3 months of vaccination

Secondary outcomes

  1. SARS-CoV-2 sustained post-infection antibody response

    Time frame: 1 year

    proportion antibody positive at one year after infection

  2. SARS-CoV-2 sustained vaccination response

    Time frame: 1 year

    proportion antibody positive at one year after vaccination

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2021
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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