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

NCT05028881 | Completed DMC

• 1 other identifier: Protocol HIV_COVID-19
• Study Type: observational
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; SARS-CoV-2 Infection; Vaccination; Infection

Keywords

HIV; COVID-19; SARS-CoV-2 vaccination; co-infection; antibody responses

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• SARS-CoV-2 sustained post-infection antibody response

  1 year

• SARS-CoV-2 sustained vaccination response

  1 year

Study Arms (2)

HIV positive

No interventions

Other: blood sampling

HIV uninfected

No interventions

Other: blood sampling

Interventions

blood sampling OTHER

blood sampling for determining antibody responses

HIV positive; HIV uninfected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Shui Shan Lee

Hong Kong, Hong Kong, 0000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples would be archived for immunological testing

MeSH Terms

Conditions

HIV Infections; COVID-19; Infections; Coinfection

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shui Shan Lee, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: August 28, 2021
• First Posted: August 31, 2021
• Study Start: May 16, 2020
• Primary Completion: May 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 24, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)