SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
Primary Purpose
SARS-CoV Infection
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
serological testing
Sponsored by
About this trial
This is an interventional diagnostic trial for SARS-CoV Infection
Eligibility Criteria
Inclusion Criteria:
- Any adult employee of the UZ Brussel at T1 who has been vaccinated at the UZ Brussel with mRNA COVID-19 vaccine (Comirnaty®) between the 19th of January and the 5th of February 2021 after participating to phase 4 of the COVEMUZ study (with a maximum of 5 days difference between blood drawel and vaccination) and has provided a signed informed consent.
Exclusion Criteria:
- UZ Brussel employees not active during the inclusion period (T1).
Sites / Locations
- Universitair ziekenhuis Brussel
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
General arm
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 mRNA 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 mRNA 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 and antibody neutralisation capacity
To document the SARS-CoV-2 antibody kinetics and antibody neutralisation capacity 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.
Full Information
NCT ID
NCT04880174
First Posted
April 16, 2021
Last Updated
May 17, 2022
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04880174
Brief Title
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
Official Title
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
July 2028 (Anticipated)
Study Completion Date
July 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).
This study is a monocentric interventional prospective and retrospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel.
To document SARS-CoV-2 seroprevalence and seroconversion among employees of the UZ Brussel after mRNA vaccination for SARS-CoV-2, namely at 8 weeks after first vaccination, 6 months after first vaccination and 12 months after first 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).
UZ Brussel employees 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. During the first weeks of the vaccination campaign, the health care workers of the UZ Brussel, were invited to receive the BNT162b2 (Pfizer) vaccine.
Consequently, the investigators aim to prospectively document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees 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 Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General arm
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 antibodies in blood.
Primary Outcome Measure Information:
Title
seroprevalence
Description
To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel after mRNA 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 mRNA 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 and antibody neutralisation capacity
Description
To document the SARS-CoV-2 antibody kinetics and antibody neutralisation capacity 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
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 mRNA COVID-19 vaccine (Comirnaty®) between the 19th of January and the 5th of February 2021 after participating to phase 4 of the COVEMUZ study (with a maximum of 5 days difference between blood drawel and vaccination) and has provided a signed informed consent.
Exclusion Criteria:
UZ Brussel employees not active during the inclusion period (T1).
Facility Information:
Facility Name
Universitair ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
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