Monitoring of COVID-19 Seroprevalence Among GHdC Staff Members

NCT04813497 | Completed DMC

• 1 other identifier: SARS-COV-2-SERO_FU-2021_GHdC
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Participants who refuse the SARS-CoV-2 vaccine

OTHER

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

Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test

OTHER

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

Participants who start with the serological test before SARS-CoV-2 vaccine

OTHER

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

Participants who received the third dose of SARS-CoV-2 vaccine

OTHER

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

Participant who received the third dose of SARS-CoV-2 vaccine and

OTHER

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

Interventions

Serology to determine SARS-CoV-2 infection DIAGNOSTIC_TEST

Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood

Participant who received the third dose of SARS-CoV-2 vaccine and; Participants who received the first dose of SARS-CoV-2 vaccine before the first serological test; Participants who received the third dose of SARS-CoV-2 vaccine; Participants who refuse the SARS-CoV-2 vaccine; Participants who start with the serological test before SARS-CoV-2 vaccine

Eligibility Criteria

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

You may qualify if:

• To be an employee or independent collaborator at the GHdC

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grand Hôpital de Charleroi: lead

Study Sites (1)

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6060, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Natahie de Visscher, MD

  Grand Hôpital de Charleroi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 24, 2021
• Study Start: February 5, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)