Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Serology to determine SARS-CoV-2 infection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 4000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6060
      • Grand Hopital de Charleroi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Participants who refuse the SARS-CoV-2 vaccine; 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; Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood
Other: Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test; 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; Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood
Other: Participants who start with the serological test before SARS-CoV-2 vaccine; 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; Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood
Other: Participants who received the third dose of SARS-CoV-2 vaccine; 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; Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood
Other: Participant who received the third dose of SARS-CoV-2 vaccine and; 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; Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Grand Hôpital de Charleroi
• Investigators: Principal Investigator: Natahie de Visscher, MD, Grand Hopital de Charleroi

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SARS-COV-2-SERO_FU-2021_GHdC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No