Serological Response to mRNA and Inactivated COVID-19 Vac... | NCT04898946

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

NCT04898946

Sponsor

Hong Kong Sanatorium & Hospital

Status

Completed

Last Update Posted

Feb 28, 2024Actual

Enrollment

480Actual

Phase

Not provided

Conditions

Covid-19 Vaccine

Interventions

CoronaVac Vaccine
BNT162b2 Vaccine

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

May 20, 2021

First Submission Date that Met QC Criteria

May 20, 2021

First Posted Date

May 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Jonpaul ST Zee, Specialist in Infectious Disease, Hong Kong Sanatorium & HospitalPrincipal Investigator

Lead Sponsor

Hong Kong Sanatorium & HospitalINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BNT162b2		Subjects who receive mRNA vaccine BNT162b2.	Biological: BNT162b2 Vaccine
CoronaVac		Subjects who receive inactivated vaccine, CoronaVac.	Biological: CoronaVac Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CoronaVac Vaccine	Biological	CoronaVac Vaccine	CoronaVac
BNT162b2 Vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonpaul Sze Tsing Zee, MBChB	Hong Kong Sanatorium & Hotel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hong Kong Sanatorium & Hospital		Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000722216	sinovac COVID-19 vaccine
D000090982	BNT162 Vaccine

Ancestor Terms

ID	Term
D000087503	mRNA Vaccines
D000087504	Nucleic Acid-Based Vaccines
D014614	Vaccines, Synthetic
D011994	Recombinant Proteins

Browse Leaves

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Browse Branches

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