SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
- Conditions
- SARS-CoV Infection
- Interventions
- Diagnostic Test: serological testing
- Registration Number
- NCT04880174
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- UZ Brussel employees not active during the inclusion period (T1).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description General arm serological testing 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
- Primary Outcome Measures
Name Time Method seroprevalence Change from baseline to 8 weeks, 6 months and 12 months timepoint 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 Change from baseline to 8 weeks, 6 months and 12 months timepoint 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
Name Time Method incidence of new definite cases Change from baseline to 8 weeks, 6 months and 12 months timepoint 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 Change from baseline to 8 weeks, 6 months and 12 months timepoint 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.
SARS-CoV-2 seroprevalence before and after vaccination Change from baseline to 8 weeks, 6 months and 12 months timepoint To compare the SARS-CoV-2 seroprevalence before vaccination with the SARS-CoV-2 prevalence after vaccination among employees of the UZ Brussel.
antigen-specificity of the SARS-CoV-2-specific T cells Change from baseline to 8 weeks, 6 months and 12 months timepoint To determine the antigen-specificity of the SARS-CoV-2-specific T cells as well as their phenotype and functionality.
antibody kinetics and antibody neutralisation capacity Change from baseline to 8 weeks, 6 months and 12 months timepoint To document the SARS-CoV-2 antibody kinetics and antibody neutralisation capacity after vaccination.
Trial Locations
- Locations (1)
Universitair ziekenhuis Brussel
🇧🇪Brussels, Belgium