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

NCT04898946 | Completed

• 1 other identifier: Covid-19 Vaccine Antibody
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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 .

Conditions

Covid-19 Vaccine

Outcome Measures

Primary Outcomes (1)

• Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine

  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

Study Arms (2)

BNT162b2

Subjects who receive mRNA vaccine BNT162b2.

Biological: BNT162b2 Vaccine

CoronaVac

Subjects who receive inactivated vaccine, CoronaVac.

Biological: CoronaVac Vaccine

Interventions

CoronaVac Vaccine BIOLOGICAL

CoronaVac Vaccine

CoronaVac

BNT162b2 Vaccine BIOLOGICAL

Covid-19 BNT162b2 Vaccine

BNT162b2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Any staff, visiting doctor, nursing student of HKSH who are aged 18 or above
• No contraindication for COVID-19 vaccination and plan to receive the intended dosages at the appropriate interval.
• A baseline serology taken within 1 week before vaccination shows no evidence of recent infection.
• No history of documented COVID-19 infection

Sponsors & Collaborators

• Hong Kong Sanatorium & Hospital: lead

Study Sites (1)

Hong Kong Sanatorium & Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

sinovac COVID-19 vaccine; BNT162 Vaccine

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Jonpaul Sze Tsing Zee, MBChB

  Hong Kong Sanatorium & Hotel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Infectious Disease

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 24, 2021
• Study Start: March 7, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)