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

Completed

• Conditions: Covid-19 Vaccine
• Interventions: Biological: BNT162b2 Vaccine; Biological: CoronaVac Vaccine

• Registration Number: NCT04898946
• Lead Sponsor: 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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-07
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BNT162b2	BNT162b2 Vaccine	Subjects who receive mRNA vaccine BNT162b2.
CoronaVac	CoronaVac Vaccine	Subjects who receive inactivated vaccine, CoronaVac.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hong Kong Sanatorium & Hospital; 🇭🇰 Hong Kong, Hong Kong