ClinicalTrials.gg
CompletedNCT04898946Updated Feb 28, 2024

Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong

An observational study in Covid-19 Vaccine, sponsored by Hong Kong Sanatorium & Hospital. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Hong Kong Sanatorium & Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
480
Ages
18 Years and older
Sex
All
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Study 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 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 .

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Conditions studied

  • Covid-19 Vaccine

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 480 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Hong Kong Sanatorium & Hospital is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Healthcare workers of HKSH who plan to receive COVID-19 vaccine

Inclusion criteria

  1. Any staff, visiting doctor, nursing student of HKSH who are aged 18 or above
  2. No for COVID-19 vaccination and plan to receive the intended dosages at the appropriate interval.
  3. A baseline serology taken within 1 week before vaccination shows no evidence of recent infection.
  4. No history of documented COVID-19 infection

Exclusion criteria

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
480 participants (actual)
Patient registry
No

Groups and cohorts

  • BNT162b2

    Subjects who receive mRNA vaccine BNT162b2.

    Biological: BNT162b2 Vaccine

  • CoronaVac

    Subjects who receive inactivated vaccine, CoronaVac.

    Biological: CoronaVac Vaccine

Interventions

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month, 3 months and 6 months post vaccination

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Study locations

1 site
  • Hong Kong Sanatorium & Hospital
    Hong Kong, Hong Kong
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Dec 2021, 9 months.

Of 134 industry-sponsored observational studies under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's 9 months is close to that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2021
First posted
May 24, 2021
StartActual
Mar 7, 2021
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
Feb 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04898946
Lead sponsor
Hong Kong Sanatorium & Hospital
Responsible party
Dr. Jonpaul ST Zee (Specialist in Infectious Disease, Hong Kong Sanatorium & Hospital) — Principal investigator
First posted
May 24, 2021
Start date
Mar 7, 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Feb 28, 2024

Study contacts

Jonpaul Sze Tsing Zee, MBChB
principal investigator · Hong Kong Sanatorium & Hotel

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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