SARS-CoV Infection Clinical Trial
Official title:
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
Verified date | May 2022 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | July 2028 |
Est. primary completion date | July 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair ziekenhuis Brussel | Brussels |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline to 8 weeks, 6 months and 12 months timepoint | |
Primary | 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 | Change from baseline to 8 weeks, 6 months and 12 months timepoint | |
Secondary | 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. | Change from baseline to 8 weeks, 6 months and 12 months timepoint | |
Secondary | 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. | Change from baseline to 8 weeks, 6 months and 12 months timepoint | |
Secondary | 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. | Change from baseline to 8 weeks, 6 months and 12 months timepoint | |
Secondary | antibody kinetics and antibody neutralisation capacity | To document the SARS-CoV-2 antibody kinetics and antibody neutralisation capacity after vaccination. | Change from baseline to 8 weeks, 6 months and 12 months timepoint | |
Secondary | 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. | Change from baseline to 8 weeks, 6 months and 12 months timepoint |
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