COVID-19 VaccinesNCT05373459
Effect of a Third COVID-19 Booster Among Health Care Workers
An observational study of COVID-19 Vaccines, run by Hong Kong Sanatorium & Hospital at 1 site in Hong Kong.
Trial summary
A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- Third COVID-19 booster
- Type of treatment
- Vaccines
- How many people
- 3,167 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 May 2022to 31 Dec 2022
- 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: All full time staff members of the private hospital
Who may be able to join
- All full time staff members of the private hospital
Who cannot join
- History of COVID-19 before 2022
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Third COVID-19 Booster on COVID-19 Infection Rate and Return to Works During Fifth Wave COVID-19 Among Health Care Workers
A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta variant. The pandemic also resulted in many infections among health care workers (HCWs) and their households. In this study, a retrospective analysis would perform on risk of COVID-19 infection and their outcome in relation to their COVID-19 vaccination history by using the data repository from one of the Hong Kong private hospitals.
HCWs were required to submit a standardized online self-declaration form for report of 1) demographic of the HCWs, 2) symptoms related history and 3) COVID-19 exposure history once they were COVID-19 confirmed by rapid antigen test against COVID-19 and/or polymerase chain reaction (PCR) test for COVID-19. Subsequent follow up such as contact tracing, COVID-19 PCR testing results of these HCWs and status of return to work were captured by the infection control team in a systematic manner.
- Conditions
- COVID-19 Vaccines
- Being tested
- Third COVID-19 booster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third COVID-19 boosterBiological
Third COVID-19 booster
| Study group | Role | What they receive |
|---|---|---|
| Health care workers without third COVID-19 booster | Health care workers received less than 3 doses of COVID-19 vaccine | |
| HCWs with third COVID-19 booster | Health care workers received at least 3 doses of COVID-19 vaccine Receives: Biological: Third COVID-19 booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Infection
Number of participants with COVID-19 infected
Measured: During 1 February - 31 March 2022
Number of days return to work after COVID-19 infection
Number of days return to work after COVID-19 infection
Measured: During 1 February - 31 March 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start16 May 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies 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
- Retrospective
- Enrolment
- 3,167 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 & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373459
- Sponsor's protocol ID
- Third COVID-19 booster
- Status last verified
- Feb 2024
- First submitted
- 12 May 2022
- Last updated
- 28 Feb 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Third COVID-19 Booster on COVID-19 Infection Rate and Return to Works During Fifth Wave COVID-19 Among Health Care Workers
- ClinicalTrials.gov ID
- NCT05373459
- Acronym / sponsor ID
- Third COVID-19 booster
- Conditions
- COVID-19 Vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,167 participants (actual)
- Lead sponsor
- Hong Kong Sanatorium & HospitalIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 May 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.
A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta variant. The pandemic also resulted in many infections among health care workers (HCWs) and their households. In this study, a retrospective analysis would perform on risk of COVID-19 infection and their outcome in relation to their COVID-19 vaccination history by using the data repository from one of the Hong Kong private hospitals.
HCWs were required to submit a standardized online self-declaration form for report of 1) demographic of the HCWs, 2) symptoms related history and 3) COVID-19 exposure history once they were COVID-19 confirmed by rapid antigen test against COVID-19 and/or polymerase chain reaction (PCR) test for COVID-19. Subsequent follow up such as contact tracing, COVID-19 PCR testing results of these HCWs and status of return to work were captured by the infection control team in a systematic manner.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care workers without third COVID-19 booster | – | –Health care workers received less than 3 doses of COVID-19 vaccine |
| HCWs with third COVID-19 booster | – | Biological: Third COVID-19 boosterHealth care workers received at least 3 doses of COVID-19 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All full time staff members of the private hospital
Key inclusion criteria (1 listed)
- All full time staff members of the private hospital
Key exclusion criteria (1 listed)
- History of COVID-19 before 2022
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 |
|---|---|---|
| Third COVID-19 boosterThird COVID-19 booster | Biological | HCWs with third COVID-19 booster |
Primary outcome
COVID-19 Infection
Time frame: During 1 February - 31 March 2022
Number of participants with COVID-19 infected
Number of days return to work after COVID-19 infection
Time frame: During 1 February - 31 March 2022
Number of days return to work after COVID-19 infection
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 & Hospital
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 Vaccines, 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 1 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?
COVID-19 Infection (time frame: During 1 February - 31 March 2022). 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 28 Feb 2024.