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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

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
Covid-19 Vaccine Biological: CoronaVac Vaccine Biological: BNT162b2 Vaccine

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Study Type : Observational
Estimated 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 : March 8, 2021
Estimated Primary Completion Date : March 8, 2022
Estimated Study Completion Date : March 8, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Healthcare workers of HKSH who plan to receive COVID-19 vaccine
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898946


Contacts
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Contact: Jonpaul Sze Tsing Zee, MBChB 28357064 Jonpaul.ST.Zee@hksh.com
Contact: Lam Fung Kwok, BscNursing 28357195 LamFung.Kwok@hksh.com

Locations
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Hong Kong
Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, Hong Kong
Contact: Jonpaul Sze Tsing Zee, MBChB    28357064    jonpaul.st.zee@hksh.com   
Sponsors and Collaborators
Hong Kong Sanatorium & Hospital
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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    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs