SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination

NCT04880174 | Active Not Recruiting

• 1 other identifier: COVEMUZ-2
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV Infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• SARS-CoV-2 seroprevalence before and after vaccination

  Change from baseline to 8 weeks, 6 months and 12 months timepoint

• incidence of new definite cases

  Change from baseline to 8 weeks, 6 months and 12 months timepoint

• incidence of new probable cases

  Change from baseline to 8 weeks, 6 months and 12 months timepoint

• antibody kinetics and antibody neutralisation capacity

  Change from baseline to 8 weeks, 6 months and 12 months timepoint

• antigen-specificity of the SARS-CoV-2-specific T cells

  Change from baseline to 8 weeks, 6 months and 12 months timepoint

Study Arms (1)

General arm

OTHER

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

Diagnostic Test: serological testing

Interventions

serological testing DIAGNOSTIC_TEST

Antibody testing for Sars-COV-2 antibodies in blood.

General arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 10, 2021
• Study Start: March 22, 2021
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)