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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04898946
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Jonpaul ST Zee, Hong Kong Sanatorium & Hospital

Tracking Information
First Submitted Date May 20, 2021
First Posted Date May 24, 2021
Last Update Posted Date June 1, 2021
Actual Study Start Date March 8, 2021
Estimated Primary Completion Date March 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2021)
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
Original Primary Outcome Measures
 (submitted: May 20, 2021)
Antibody against Covid-19 [ Time Frame: 6 months after second dose of vaccine ]
Antibody against Covid-19 should be present
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong
Official Title Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong
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 .

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Healthcare workers of HKSH who plan to receive COVID-19 vaccine
Condition Covid-19 Vaccine
Intervention
  • Biological: CoronaVac Vaccine
    CoronaVac Vaccine
  • Biological: BNT162b2 Vaccine
    Covid-19 BNT162b2 Vaccine
Study Groups/Cohorts
  • BNT162b2
    Subjects who receive mRNA vaccine BNT162b2.
    Intervention: Biological: BNT162b2 Vaccine
  • CoronaVac
    Subjects who receive inactivated vaccine, CoronaVac.
    Intervention: Biological: CoronaVac Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2021)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 8, 2022
Estimated Primary Completion Date March 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jonpaul Sze Tsing Zee, MBChB 28357064 Jonpaul.ST.Zee@hksh.com
Contact: Lam Fung Kwok, BscNursing 28357195 LamFung.Kwok@hksh.com
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT04898946
Other Study ID Numbers Covid-19 Vaccine Antibody
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Jonpaul ST Zee, Hong Kong Sanatorium & Hospital
Study Sponsor Hong Kong Sanatorium & Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Hong Kong Sanatorium & Hospital
Verification Date May 2021