Covid-19 VaccineNCT04898946
Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong
An observational study of Covid-19 Vaccine, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
Trial summary
Since the first local case of COVID-19 confirmed on 4 Feb 2020, Hong Kong has already experienced 4 waves of COVID-19 surge, with more than 9000 cases reported. A number of vaccines have been shown to be efficacious against symptomatic and severe infection by inducing neutralizing antibody (NAB) against spike protein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19 Vaccine
- What is being tested?
- CoronaVac Vaccine and BNT162b2 Vaccine
- Type of treatment
- Vaccines
- How many people
- 480 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Mar 2021to 31 Dec 2021
- 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
- Adult, Older adult
Study population: Healthcare workers of HKSH who plan to receive COVID-19 vaccine
Who may be able to join
- Any staff, visiting doctor, nursing student of HKSH who are aged 18 or above
- No contraindication for COVID-19 vaccination and plan to receive the intended dosages at the appropriate interval.
- A baseline serology taken within 1 week before vaccination shows no evidence of recent infection.
- No history of documented COVID-19 infection
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Since the first local case of COVID-19 confirmed on 4 Feb 2020, Hong Kong has already experienced 4 waves of COVID-19 surge, with more than 9000 cases reported. A number of vaccines have been shown to be efficacious against symptomatic and severe infection by inducing neutralizing antibody (NAB) against spike protein of the SARS-CoV-2 virus. However, the duration of protection and longevity of antibody response is unknown.
Health care workers (HCWs) who are planning to receive COVID-19 vaccine will be recruited. The level of antibody against spike protein by different quantitative assays will also be serially measured .
- Conditions
- Covid-19 Vaccine
- Being tested
- CoronaVac Vaccine, BNT162b2 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronaVac VaccineBiological
CoronaVac Vaccine
BNT162b2 VaccineBiological
Covid-19 BNT162b2 Vaccine
| Study group | Role | What they receive |
|---|---|---|
| BNT162b2 | Subjects who receive mRNA vaccine BNT162b2. Receives: Biological: BNT162b2 Vaccine | |
| CoronaVac | Subjects who receive inactivated vaccine, CoronaVac. Receives: Biological: CoronaVac Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine
Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine at different points during the first six months of vaccination
Measured: 1 month, 3 months and 6 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start7 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 VaccineStudies of the same condition, open and under way.
- 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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Sanatorium & Hospital
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Jonpaul ST Zee, Hong Kong Sanatorium & Hospital
- Investigators
- Jonpaul Sze Tsing Zee, MBChB, Principal investigator, Hong Kong Sanatorium & Hotel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898946
- Sponsor's protocol ID
- Covid-19 Vaccine Antibody
- Status last verified
- Feb 2024
- First submitted
- 20 May 2021
- Last updated
- 28 Feb 2024
- Results posted
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong
- ClinicalTrials.gov ID
- NCT04898946
- Acronym / sponsor ID
- Covid-19 Vaccine Antibody
- Conditions
- Covid-19 Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Hong Kong Sanatorium & HospitalIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 May 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.
Since the first local case of COVID-19 confirmed on 4 Feb 2020, Hong Kong has already experienced 4 waves of COVID-19 surge, with more than 9000 cases reported. A number of vaccines have been shown to be efficacious against symptomatic and severe infection by inducing neutralizing antibody (NAB) against spike protein of the SARS-CoV-2 virus. However, the duration of protection and longevity of antibody response is unknown.
Health care workers (HCWs) who are planning to receive COVID-19 vaccine will be recruited. The level of antibody against spike protein by different quantitative assays will also be serially measured .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNT162b2 | – | Biological: BNT162b2 VaccineSubjects who receive mRNA vaccine BNT162b2. |
| CoronaVac | – | Biological: CoronaVac VaccineSubjects who receive inactivated vaccine, CoronaVac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers of HKSH who plan to receive COVID-19 vaccine
Key inclusion criteria (4 listed)
- Any staff, visiting doctor, nursing student of HKSH who are aged 18 or above
- No contraindication for COVID-19 vaccination and plan to receive the intended dosages at the appropriate interval.
- A baseline serology taken within 1 week before vaccination shows no evidence of recent infection.
- No history of documented COVID-19 infection
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| CoronaVac VaccineCoronaVac Vaccine | Biological | CoronaVac |
| BNT162b2 VaccineCovid-19 BNT162b2 Vaccine | Biological | BNT162b2 |
Primary outcome
Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine
Time frame: 1 month, 3 months and 6 months post vaccination
Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine at different points during the first six months of vaccination
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 28 Feb 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.
Jonpaul Sze Tsing Zee, MBChB principal investigator
Hong Kong Sanatorium & Hotel
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 Vaccine, run by Hong Kong Sanatorium & Hospital 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 4 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 28 Feb 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?
Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine (time frame: 1 month, 3 months and 6 months post vaccination). 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 28 Feb 2024.