Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

Sponsor
Grand Hôpital de Charleroi (Other)
Overall Status
Completed
CT.gov ID
NCT04813497
Collaborator
(none)
4,000
1
5
14.8
271.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serology to determine SARS-CoV-2 infection
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
4000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members: Protocol for an Interventional Cohort Study in 2020-2021
Actual Study Start Date :
Feb 5, 2021
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Serological tests to know the level of antibodies against SARS CoV-2 [up to 14 weeks after the second dose of SARS-CoV-2 vaccine or after the first serological test]

    Participants accept to undergo 2 serological tests to determine their immunity to the SARS-CoV-2 virus.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grand Hôpital de Charleroi Charleroi Hainaut Belgium 6060

Sponsors and Collaborators

  • Grand Hôpital de Charleroi

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Grand Hôpital de Charleroi
ClinicalTrials.gov Identifier:
NCT04813497
Other Study ID Numbers:
  • SARS-COV-2-SERO_FU-2021_GHdC
First Posted:
Mar 24, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022