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SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the UZ Brussel Following COVID-19 Vaccination Using an Adenoviral Vector

Primary Purpose

SARS-CoV-2, Covid19

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Serological testing
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any adult employee of the UZ Brussel at T1 who has been vaccinated at the UZ Brussel with ChAdOx1 nCoV-19 vaccine between the 2nd of March and the 9th of March 2021 after participating to phase 4 of the COVEMUZ study between the 25th of January and the 12th of February and has provided a signed informed consent.

Exclusion Criteria:

  • UZ Brussel employees not active during the inclusion period (T1).

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

General

Arm Description

All patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points

Outcomes

Primary Outcome Measures

Seroprevalence
To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel after ChAdOx1 nCoV-19 vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies
Seroconversion
To document SARS-CoV-2 seroconversion among employees of the UZ Brussel after ChAdOx1 nCoV-19 vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies

Secondary Outcome Measures

SARS-CoV-2 seroprevalence before and after vaccination
To compare the SARS-CoV-2 seroprevalence before vaccination with the SARS-CoV-2 prevalence after vaccination among employees of the UZ Brussel.
incidence of new definite cases
To document the incidence of new definite cases of COVID-19 (based on self-reported positive PCR testing on nasopharyngeal swab) among vaccinated employees of the UZ Brussel over a period of a year.
incidence of new probable cases
To document the incidence of new probable cases of COVID-19 (based on the study questionnaire filled in by the participants) among vaccinated employees of the UZ Brussel over a period of a year.
antibody kinetics of the SARS-CoV-2 specific antibodies using immunassays
To document the SARS-CoV-2 antibody kinetics after vaccination.
antigen-specificity of the SARS-CoV-2-specific T cells
To determine the antigen-specificity of the SARS-CoV-2-specific T cells as well as their phenotype and functionality
antibody neutralisation capacity of the SARS-CoV-2 specific B cells using immunassays
To document the SARS-CoV-2 antibody neutralisation capacity after vaccination.

Full Information

First Posted
April 22, 2021
Last Updated
May 17, 2022
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04939402
Brief Title
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the UZ Brussel Following COVID-19 Vaccination Using an Adenoviral Vector
Official Title
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following COVID-19 Vaccination Using an Adenoviral Vector
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19). Employees of the university hospital of Brussels (UZ Brussel) presenting symptoms suggestive of COVID-19 are offered to be tested with real-time PCR on nasopharyngeal swabs. As asymptomatic infections have been described and as the PCR can be negative when taken late after onset of symptoms, serologic tests can be performed. The SARS-CoV 2003 epidemic demonstrated that serological assays were a useful diagnostic tool of non-acute infections. Although it is still uncertain whether convalescing patients have a risk of re-infection, recent data suggest that SARS-CoV-2 antibodies could protect at least for some time from subsequent viral exposures. As the COVID-19 pandemic had devastating medical, economic and social consequences, safe and effective prophylactic vaccines were urgently needed. And thus several candidate vaccines against SARS-CoV-2 have been developed. The vaccination campaign of the health care workers of the UZ Brussel started mid January 2021. The first available vaccine was the BNT162b2 (Pfizer) vaccine. Early March 2021, in order to accelerate the vaccination of the UZ Brussel employees, the ChAdOx1 nCoV-19 (AZD12222) (Oxford, AstaZeneca) vaccination program was implemented in parallel with the BNT162b2 vaccination program In the COVEMUZ-2 study the investigators have already started to document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using BNT162b2) in the UZ Brussels. In this study, the investigators aim to prospectively document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using ChAdOx1 nCoV-19) of the UZ Brussel, at three different time points, namely 6 weeks (+/- 2 weeks; T1), 6 months (+/- 1 month; T2) and 12 months (+/- 1 month; T3) after the second vaccination.
Detailed Description
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19). Employees of the university hospital of Brussels (UZ Brussel) presenting symptoms suggestive of COVID-19 are offered to be tested with real-time PCR on nasopharyngeal swabs. As asymptomatic infections have been described and as the PCR can be negative when taken late after onset of symptoms, serologic tests can be performed. The SARS-CoV 2003 epidemic demonstrated that serological assays were a useful diagnostic tool of non-acute infections. Although it is still uncertain whether convalescing patients have a risk of re-infection, recent data suggest that SARS-CoV-2 antibodies could protect at least for some time from subsequent viral exposures. As the COVID-19 pandemic had devastating medical, economic and social consequences, safe and effective prophylactic vaccines were urgently needed. And thus several candidate vaccines against SARS-CoV-2 have been developed. The vaccination campaign of the health care workers of the UZ Brussel started mid January 2021. The first available vaccine was the BNT162b2 (Pfizer) vaccine. Early March 2021, in order to accelerate the vaccination of the UZ Brussel employees, the ChAdOx1 nCoV-19 (AZD12222) (Oxford, AstaZeneca) vaccination program was implemented in parallel with the BNT162b2 vaccination program In the COVEMUZ-2 study the investigators have already started to document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using BNT162b2) in the UZ Brussels. In this study, the investigators aim to prospectively document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using ChAdOx1 nCoV-19) of the UZ Brussel, at three different time points, namely 6 weeks (+/- 2 weeks; T1), 6 months (+/- 1 month; T2) and 12 months (+/- 1 month; T3) after the second vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2, Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General
Arm Type
Other
Arm Description
All patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points
Intervention Type
Diagnostic Test
Intervention Name(s)
Serological testing
Intervention Description
Antibody testing for Sars-CoV-2 specific antibodies in blood + T cell immunity
Primary Outcome Measure Information:
Title
Seroprevalence
Description
To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel after ChAdOx1 nCoV-19 vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint
Title
Seroconversion
Description
To document SARS-CoV-2 seroconversion among employees of the UZ Brussel after ChAdOx1 nCoV-19 vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint
Secondary Outcome Measure Information:
Title
SARS-CoV-2 seroprevalence before and after vaccination
Description
To compare the SARS-CoV-2 seroprevalence before vaccination with the SARS-CoV-2 prevalence after vaccination among employees of the UZ Brussel.
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint
Title
incidence of new definite cases
Description
To document the incidence of new definite cases of COVID-19 (based on self-reported positive PCR testing on nasopharyngeal swab) among vaccinated employees of the UZ Brussel over a period of a year.
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint
Title
incidence of new probable cases
Description
To document the incidence of new probable cases of COVID-19 (based on the study questionnaire filled in by the participants) among vaccinated employees of the UZ Brussel over a period of a year.
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint
Title
antibody kinetics of the SARS-CoV-2 specific antibodies using immunassays
Description
To document the SARS-CoV-2 antibody kinetics after vaccination.
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint
Title
antigen-specificity of the SARS-CoV-2-specific T cells
Description
To determine the antigen-specificity of the SARS-CoV-2-specific T cells as well as their phenotype and functionality
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint
Title
antibody neutralisation capacity of the SARS-CoV-2 specific B cells using immunassays
Description
To document the SARS-CoV-2 antibody neutralisation capacity after vaccination.
Time Frame
Change from baseline to 8 weeks, 6 months and 12 months timepoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any adult employee of the UZ Brussel at T1 who has been vaccinated at the UZ Brussel with ChAdOx1 nCoV-19 vaccine between the 2nd of March and the 9th of March 2021 after participating to phase 4 of the COVEMUZ study between the 25th of January and the 12th of February and has provided a signed informed consent. Exclusion Criteria: UZ Brussel employees not active during the inclusion period (T1).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Allard, phd, md
Phone
+32 2 477
Ext
60 01
Email
sabine.allard@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Virgini Van Buggenhout
Phone
+32 2 477
Ext
6001
Email
virgini.vanbuggenhout@uzbrussel.be
Facility Information:
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Allard, PHD, MD
Phone
3389
Ext
02 477
Email
sabine.allard@uzbrussel.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the UZ Brussel Following COVID-19 Vaccination Using an Adenoviral Vector

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