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

February 26, 2024 updated by: Dr. Jonpaul ST Zee, Hong Kong Sanatorium & Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Hong Kong Sanatorium & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Any staff, visiting doctor, nursing student of HKSH who are aged 18 or above
  2. No contraindication 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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BNT162b2
Subjects who receive mRNA vaccine BNT162b2.
Biological: BNT162b2 Vaccine
Covid-19 BNT162b2 Vaccine
CoronaVac
Subjects who receive inactivated vaccine, CoronaVac.
Biological: CoronaVac Vaccine
CoronaVac Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month, 3 months and 6 months post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Sanatorium & Hospital

Investigators

  • Principal Investigator: Jonpaul Sze Tsing Zee, MBChB, Hong Kong Sanatorium & Hotel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Covid-19 Vaccine Antibody

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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