Clinical trial NCT05028881: COVID-19 Serology in People Living with HIV in Hong Kong
Official title: Serological Responses to SARS-CoV-2 and Their Temporal Pattern in HIV Infected Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
SARS-CoV-2 Infection
Vaccination; Infection
Keywords: HIV
COVID-19
SARS-CoV-2 vaccination
co-infection
antibody responses
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. .

Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 antibody early response to infection
timeFrame: 3 months
measure: SARS-CoV-2 antibody early response to vaccination
timeFrame: 3 months
Secondary outcomes:
measure: SARS-CoV-2 sustained post-infection antibody response
timeFrame: 1 year
measure: SARS-CoV-2 sustained vaccination response
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Shui Shan Lee
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Shui Shan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: