COVID-19NCT05599555
Community-based Sero-epidemiological Study of COVID-19
An observational study of COVID-19, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Using detailed serial cross-sectional estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels, the investigators derived age-specific infection attack rates and age-specific population immunity levels and tracked the magnitude of individual-level and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- mRNA BNT162b2 vaccine and CoronaVac vaccine
- Type of treatment
- Vaccines
- How many people
- 9,600 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Apr 2022to 31 Mar 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy blood donors in Hong Kong aged between 18 and 65 years old
Who may be able to join
- Have good health
- Weigh 41 kg or above (90 lbs or above)
- Aged between 18 and 65
Who cannot join
- Individuals who are not eligible for blood donation in Hong Kong
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community-based Sero-epidemiological Study of COVID-19 to Provide Data in Real Time on Age-stratified Infection Attack Rates, Disease Severity and Population Immunity, for Guiding Intervention Policy
Using detailed serial cross-sectional estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels, the investigators derived age-specific infection attack rates and age-specific population immunity levels and tracked the magnitude of individual-level and population-level waning immunity over time. The findings will inform health policy makers on devising future public health and social measures and vaccination guidance in response to the ongoing COVID-19 pandemic.
Read the detailed description
Since December 2021, the SARS-CoV-2 B.1.1.529 (Omicron) variant started spreading in Hong Kong, leading to an unprecedented 5th wave. It is known that the Omicron variant may partially evade immunity from past vaccination and infection although both appear to protect from severe disease and death. As Hong Kong emerges from the 5th wave, it will be critically important for public health policy to assess the proportion of the population with evidence of natural infection and those with evidence of detectable neutralizing antibody to the Omicron variant, either though natural infection or vaccination. Our project aims to assess these parameters.
The investigators recruited healthy blood donors by convenience sampling at the five largest blood donation centres (Mongkok, Causeway, Kwun Tong, Tsuen Wan and Shatin) of the Hong Kong Red Cross Blood Transfusion Service (HKRCBTS). Blood donors were matched by the HKRCBTS and the Hong Kong Department of Health with official vaccination records via unique Blood Transfusion Service donor identification numbers. The records were then anonymised and provided to the study team. Blood donors were also provided with the option of self-reporting their vaccination and COVID-19 infection history.
Since the investigators need to distinguish past infection from vaccine induced immunity, they used serological test strategies that would differentiate natural infection from vaccine immunity. The investigators have previously shown that IgG antibody to the Nucleocapsid protein of SARS-CoV-2 (whole protein and the C-terminal domain) provides evidence of past infection and is not elicited by BNT162b2 vaccine but may be elicited by CoronaVac vaccine (Wu et al. 2021, Mok et al. 2021) . They have also shown IgG antibody to ORF8 is elicited by past infection and not by either CoronaVac or BNT162b2 (Hachim et al. 2020). The investigators used these assays to assess evidence of natural infection in blood donor samples.
Through the above procedures, the investigators obtained detailed serial cross-sectional (weekly between mid-April and the end of July, followed by monthly until the end of 2022) estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels. The investigators derived age-specific infection attack rates and age-specific population immunity levels and tracked the magnitude of individual-level and population-level waning immunity over time.
- Conditions
- COVID-19
- Being tested
- mRNA BNT162b2 vaccine, CoronaVac vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA BNT162b2 vaccineBiological
mRNA vaccine Comirnaty (BNT162b2 mRNA, BioNTech/Fosun-Pharma, Mainz, Germany/Shanghai, China)
CoronaVac vaccineBiological
Inactivated CoronaVac vaccine (Sinovac Life Sciences, Beijing, China)
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated blood donors | Blood donors who were unvaccinated with any COVID-19 vaccine by study recruitment | |
| Blood donors vaccinated with BNT162b2 | Blood donors who were vaccinated with one or more doses of the mRNA vaccine Comirnaty (BNT162b2 mRNA, BioNTech/Fosun-Pharma, Mainz, Germany/Shanghai, China) by study recruitment. Receives: Biological: mRNA BNT162b2 vaccine | |
| Blood donors vaccinated with CoronaVac | Blood donors who were vaccinated with one or more doses of the inactivated CoronaVac (Sinovac life Sciences, Beijing, China) vaccine by study recruitment. Receives: Biological: CoronaVac vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 seropositivity
Study subject is seropositive with SARS-CoV-2 anti-N (unvaccinated or BNT162b2 vaccinated donors only) or anti-ORF8 (CoronaVac vaccinated donors only) antibodies.
Measured: 28 April 2022 to 31 December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start28 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by The 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 9,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph T Wu, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599555
- Sponsor's protocol ID
- UW 20-132
- Status last verified
- Sep 2022
- First submitted
- 28 Oct 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Sero-epidemiological Study of COVID-19 to Provide Data in Real Time on Age-stratified Infection Attack Rates, Disease Severity and Population Immunity, for Guiding Intervention Policy
- ClinicalTrials.gov ID
- NCT05599555
- Acronym / sponsor ID
- UW 20-132
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,600 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 31 Oct 2022 (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.
Using detailed serial cross-sectional estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels, the investigators derived age-specific infection attack rates and age-specific population immunity levels and tracked the magnitude of individual-level and population-level waning immunity over time. The findings will inform health policy makers on devising future public health and social measures and vaccination guidance in response to the ongoing COVID-19 pandemic.
Detailed description
Since December 2021, the SARS-CoV-2 B.1.1.529 (Omicron) variant started spreading in Hong Kong, leading to an unprecedented 5th wave. It is known that the Omicron variant may partially evade immunity from past vaccination and infection although both appear to protect from severe disease and death. As Hong Kong emerges from the 5th wave, it will be critically important for public health policy to assess the proportion of the population with evidence of natural infection and those with evidence of detectable neutralizing antibody to the Omicron variant, either though natural infection or vaccination. Our project aims to assess these parameters.
The investigators recruited healthy blood donors by convenience sampling at the five largest blood donation centres (Mongkok, Causeway, Kwun Tong, Tsuen Wan and Shatin) of the Hong Kong Red Cross Blood Transfusion Service (HKRCBTS). Blood donors were matched by the HKRCBTS and the Hong Kong Department of Health with official vaccination records via unique Blood Transfusion Service donor identification numbers. The records were then anonymised and provided to the study team. Blood donors were also provided with the option of self-reporting their vaccination and COVID-19 infection history.
Since the investigators need to distinguish past infection from vaccine induced immunity, they used serological test strategies that would differentiate natural infection from vaccine immunity. The investigators have previously shown that IgG antibody to the Nucleocapsid protein of SARS-CoV-2 (whole protein and the C-terminal domain) provides evidence of past infection and is not elicited by BNT162b2 vaccine but may be elicited by CoronaVac vaccine (Wu et al. 2021, Mok et al. 2021) . They have also shown IgG antibody to ORF8 is elicited by past infection and not by either CoronaVac or BNT162b2 (Hachim et al. 2020). The investigators used these assays to assess evidence of natural infection in blood donor samples.
Through the above procedures, the investigators obtained detailed serial cross-sectional (weekly between mid-April and the end of July, followed by monthly until the end of 2022) estimates of the age-specific distribution of SARS-CoV-2 Omicron variant-specific antibody positivity levels. The investigators derived age-specific infection attack rates and age-specific population immunity levels and tracked the magnitude of individual-level and population-level waning immunity over time.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated blood donors | – | –Blood donors who were unvaccinated with any COVID-19 vaccine by study recruitment |
| Blood donors vaccinated with BNT162b2 | – | Biological: mRNA BNT162b2 vaccineBlood donors who were vaccinated with one or more doses of the mRNA vaccine Comirnaty (BNT162b2 mRNA, BioNTech/Fosun-Pharma, Mainz, Germany/Shanghai, China) by study recruitment. |
| Blood donors vaccinated with CoronaVac | – | Biological: CoronaVac vaccineBlood donors who were vaccinated with one or more doses of the inactivated CoronaVac (Sinovac life Sciences, Beijing, China) vaccine by study recruitment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy blood donors in Hong Kong aged between 18 and 65 years old
Key inclusion criteria (3 listed)
- Have good health
- Weigh 41 kg or above (90 lbs or above)
- Aged between 18 and 65
Key exclusion criteria (1 listed)
- Individuals who are not eligible for blood donation in Hong Kong
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 |
|---|---|---|
| mRNA BNT162b2 vaccinemRNA vaccine Comirnaty (BNT162b2 mRNA, BioNTech/Fosun-Pharma, Mainz, Germany/Shanghai, China) | Biological | Blood donors vaccinated with BNT162b2 |
| CoronaVac vaccineInactivated CoronaVac vaccine (Sinovac Life Sciences, Beijing, China) | Biological | Blood donors vaccinated with CoronaVac |
Primary outcome
Covid-19 seropositivity
Time frame: 28 April 2022 to 31 December 2022
Study subject is seropositive with SARS-CoV-2 anti-N (unvaccinated or BNT162b2 vaccinated donors only) or anti-ORF8 (CoronaVac vaccinated donors only) antibodies.
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Joseph T Wu principal investigator
The 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 COVID-19, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 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 11 Dec 2024. 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 Hong Kong. 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?
Covid-19 seropositivity (time frame: 28 April 2022 to 31 December 2022). 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 11 Dec 2024.