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临床试验/NCT05028881
NCT05028881已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 488 人开始时间: 2020年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
488
试验地点
1
主要终点
SARS-CoV-2 antibody early response to infection

研究概览

简要总结

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.

详细描述

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. .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults of age 18 or above, with
  • known HIV status
  • infection with SARS-CoV-2 or completion of vaccination against SARS-CoV-2

排除标准

  • unable to communicate in written/spoken Chinese or English
  • concurrent mental illnesses
  • prisoners
  • absence of consent

结局指标

主要结局

SARS-CoV-2 antibody early response to infection

时间窗: 3 months

proportion antibody positive within 3 months of infection

SARS-CoV-2 antibody early response to vaccination

时间窗: 3 months

proportion antibody positive within 3 months of vaccination

次要结局

  • SARS-CoV-2 sustained post-infection antibody response(1 year)
  • SARS-CoV-2 sustained vaccination response(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shui-Shan Lee, MD

Research Professor

Chinese University of Hong Kong

研究点 (1)

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