HIV InfectionsNCT05028881
COVID-19 Serology in People Living with HIV in Hong Kong
An observational study of HIV Infections and SARS-CoV-2 Infection, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, SARS-CoV-2 Infection, Vaccination; Infection
- What is being tested?
- blood sampling
- How many people
- 488 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2020to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- adults of age 18 or above, with
- known HIV status
- infection with SARS-CoV-2 or completion of vaccination against SARS-CoV-2
Who cannot join
- unable to communicate in written/spoken Chinese or English
- concurrent mental illnesses
- prisoners
- absence of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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. .
- Conditions
- HIV Infections, SARS-CoV-2 Infection, Vaccination; Infection
- Being tested
- blood sampling
- Keywords
- HIV, COVID-19, SARS-CoV-2 vaccination, co-infection, antibody responses
- Medical subject headings
- HIV Infections, COVID-19, Infections, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
blood sampling for determining antibody responses
| Study group | Role | What they receive |
|---|---|---|
| HIV positive | No interventions Receives: Other: blood sampling | |
| HIV uninfected | No interventions Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 antibody early response to infection
proportion antibody positive within 3 months of infection
Measured: 3 months
SARS-CoV-2 antibody early response to vaccination
proportion antibody positive within 3 months of vaccination
Measured: 3 months
Secondary outcomes (2)
SARS-CoV-2 sustained post-infection antibody response
proportion antibody positive at one year after infection
Measured: 1 year
SARS-CoV-2 sustained vaccination response
proportion antibody positive at one year after vaccination
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start16 May 2020
- Primary completion15 May 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shui-Shan Lee, MD, Chinese University of Hong Kong
- Investigators
- Shui Shan Lee, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028881
- Sponsor's protocol ID
- Protocol HIV_COVID-19
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data are kept in confidence and would not be available to researchers outside the study, as has been bound by ethics approval
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Responses to SARS-CoV-2 and Their Temporal Pattern in HIV Infected Persons
- ClinicalTrials.gov ID
- NCT05028881
- Acronym / sponsor ID
- Protocol HIV_COVID-19
- Conditions
- HIV Infections, SARS-CoV-2 Infection, Vaccination; Infection
- Keywords
- HIV, COVID-19, SARS-CoV-2 vaccination, co-infection, antibody responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 16 May 2020 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV positive | – | Other: blood samplingNo interventions |
| HIV uninfected | – | Other: blood samplingNo interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- adults of age 18 or above, with
- known HIV status
- infection with SARS-CoV-2 or completion of vaccination against SARS-CoV-2
Key exclusion criteria (4 listed)
- unable to communicate in written/spoken Chinese or English
- concurrent mental illnesses
- prisoners
- absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood sampling for determining antibody responses | Other | HIV positive, HIV uninfected |
Primary outcome
SARS-CoV-2 antibody early response to infection
Time frame: 3 months
proportion antibody positive within 3 months of infection
SARS-CoV-2 antibody early response to vaccination
Time frame: 3 months
proportion antibody positive within 3 months of vaccination
2 secondary outcomes
SARS-CoV-2 sustained post-infection antibody response
Time frame: 1 year
SARS-CoV-2 sustained vaccination response
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. Individual data are kept in confidence and would not be available to researchers outside the study, as has been bound by ethics approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shui Shan Lee, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and SARS-CoV-2 Infection, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 antibody early response to infection (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.