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

Sponsor
Hong Kong Sanatorium & Hospital (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04898946
Collaborator
(none)
400
Enrollment
1
Location
12
Anticipated Duration (Months)
33.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease Intervention/Treatment Phase
  • Biological: CoronaVac Vaccine
  • Biological: BNT162b2 Vaccine

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong
Actual Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Mar 8, 2022
Anticipated Study Completion Date :
Mar 8, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hong Kong Sanatorium & Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • Hong Kong Sanatorium & Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Jonpaul ST Zee, Specialist in Infectious Disease, Hong Kong Sanatorium & Hospital
ClinicalTrials.gov Identifier:
NCT04898946
Other Study ID Numbers:
  • Covid-19 Vaccine Antibody
First Posted:
May 24, 2021
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Vaccines

Study Results

No Results Posted as of Jun 1, 2021