Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

Study Overview
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Brief Summary
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Grand Hôpital de Charleroi (GHdC) had to organize the vaccination of its staff in December 2021 against SARS-CoV-2.On the sidelines of this vaccination campaign, the management committee agreed to document the knowledge of the SARS-CoV-2 serology of all the staff of the establishment before this vaccination campaign, as well as a few weeks after vaccination. In November 2021, the Belgian government decided to offer a third dose of vaccine against SARS-CoV-2 virus. The GHdC managment committee has agreed to continue monitoring SARS-CoV-2 serology for members who receive their third dose of vaccine.

Detailed Description
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Grand Hôpital de Charleroi (GHdC) staff were exposed to the risk of SARS-CoV-2 infection during the first half of 2020: a seroprevalence survey, conducted in the summer of 2020, after the first wave of the epidemic, and before the second wave, thus revealed a significant seroprevalence because of its exposure. This study, because of its high participation rate, also showed the sustained interest of the agents in knowing their serology, either for personal reasons, or for the purposes of recognition as an occupational disease. The GHdC decided in December 2020 to organize as soon as possible the vaccination of its salaried and self-employed employees who wish to take advantage of this opportunity. On the sidelines of this vaccination campaign, the management committee agreed to document the knowledge of the SARS-Cov-2 serology of all the staff of the establishment before this vaccination campaign, as well as a few weeks after vaccination. This knowledge must better organize the disease prevention strategy, both with regard to the staff themselves and the patients for whom they are called upon to treat. When the Belgian government decided in November 2021 to offer a third dose of vaccine and start it up in hospitals, the GHdC managment committee has agreed to continue monitoring SARS-CoV-2 serology for members who agree to receive their third dose of vaccine.

Official Title
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Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members: Protocol for an Interventional Cohort Study in 2020-2021

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Serology to determine SARS-CoV-2 infection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be an employee or independent collaborator at the GHdC Exclusion Criteria: Refusal to take a blood test for anti-SARS-CoV-2 antibodies Regarding amendment 1: Members who did not receive the third dose of PFIZER vaccine (Comirnaty) during the GHdC vaccination campaign and who did not performed a blood test to measure anti-SARS-CoV-2 antibodies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 : participants who did not agree to receive a SARS-CoV-2 vaccine in the first Belgian campaing but who agreed to perform a serological test against COVID-19. Groups of participants who agree to receive a SARS-CoV-2 vaccine at different specific times determined by the Belgian State for workers at the Grand Hôpital de Charleroi. Parallel study of immunity to SARS-CoV-2 among staff members.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants who refuse the SARS-CoV-2 vaccine<br>Participant who does not wish to be vaccinated against the SARS-CoV-2 virus and who wishes to perform the serological test during the vaccination campaign and the second 12-14 weeks after the first serological test. | Diagnostic Test: Serology to determine SARS-CoV-2 infection<br>* Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood<br>|
| Other: Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test<br>Participant who has received his first dose of vaccine and who performs his serological test when he receives the second dose of vaccine against the SARS-CoV-2 virus to determine his immunity. The second serological test will be done 12 to 14 weeks after the second dose of the SARS-CoV-2 vaccine to determine its immunity. | Diagnostic Test: Serology to determine SARS-CoV-2 infection<br>* Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood<br>|
| Other: Participants who start with the serological test before SARS-CoV-2 vaccine<br>Participant who performed the serological test before the first dose of vaccine and 12 to 14 weeks after the second dose of vaccine against the SARS-CoV-2 virus to determine his immunity. | Diagnostic Test: Serology to determine SARS-CoV-2 infection<br>* Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood<br>|
| Other: Participants who received the third dose of SARS-CoV-2 vaccine<br>Participant who performs his serological test when he receives the third dose of vaccine against the SARS-CoV-2 virus to determine his immunity. | Diagnostic Test: Serology to determine SARS-CoV-2 infection<br>* Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood<br>|
| Other: Participant who received the third dose of SARS-CoV-2 vaccine and<br>Participant who performs a serological test between 12 and 14 weeks after the third dose of SARS-CoV-2 vaccine to determine immunity. And who has agreed to undergo serological testing prior to the third dose of the vaccine. | Diagnostic Test: Serology to determine SARS-CoV-2 infection<br>* Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological tests to know the level of antibodies against SARS CoV-2 | Participants accept to undergo 2 serological tests to determine their immunity to the SARS-CoV-2 virus. | up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test |