Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04939402

SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the UZ Brussel Following COVID-19 Vaccination Using an Adenoviral Vector

SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following COVID-19 Vaccination Using an Adenoviral Vector

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Universitair Ziekenhuis Brussel · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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). Employees of the university hospital of Brussels (UZ Brussel) presenting symptoms suggestive of COVID-19 are offered to be tested with real-time PCR on nasopharyngeal swabs. As asymptomatic infections have been described and as the PCR can be negative when taken late after onset of symptoms, serologic tests can be performed. The SARS-CoV 2003 epidemic demonstrated that serological assays were a useful diagnostic tool of non-acute infections. Although it is still uncertain whether convalescing patients have a risk of re-infection, recent data suggest that SARS-CoV-2 antibodies could protect at least for some time from subsequent viral exposures. As the COVID-19 pandemic had devastating medical, economic and social consequences, safe and effective prophylactic vaccines were urgently needed. And thus several candidate vaccines against SARS-CoV-2 have been developed. The vaccination campaign of the health care workers of the UZ Brussel started mid January 2021. The first available vaccine was the BNT162b2 (Pfizer) vaccine. Early March 2021, in order to accelerate the vaccination of the UZ Brussel employees, the ChAdOx1 nCoV-19 (AZD12222) (Oxford, AstaZeneca) vaccination program was implemented in parallel with the BNT162b2 vaccination program In the COVEMUZ-2 study the investigators have already started to document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using BNT162b2) in the UZ Brussels. In this study, the investigators aim to prospectively document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using ChAdOx1 nCoV-19) of the UZ Brussel, at three different time points, namely 6 weeks (+/- 2 weeks; T1), 6 months (+/- 1 month; T2) and 12 months (+/- 1 month; T3) after the second vaccination.

Detailed description

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). Employees of the university hospital of Brussels (UZ Brussel) presenting symptoms suggestive of COVID-19 are offered to be tested with real-time PCR on nasopharyngeal swabs. As asymptomatic infections have been described and as the PCR can be negative when taken late after onset of symptoms, serologic tests can be performed. The SARS-CoV 2003 epidemic demonstrated that serological assays were a useful diagnostic tool of non-acute infections. Although it is still uncertain whether convalescing patients have a risk of re-infection, recent data suggest that SARS-CoV-2 antibodies could protect at least for some time from subsequent viral exposures. As the COVID-19 pandemic had devastating medical, economic and social consequences, safe and effective prophylactic vaccines were urgently needed. And thus several candidate vaccines against SARS-CoV-2 have been developed. The vaccination campaign of the health care workers of the UZ Brussel started mid January 2021. The first available vaccine was the BNT162b2 (Pfizer) vaccine. Early March 2021, in order to accelerate the vaccination of the UZ Brussel employees, the ChAdOx1 nCoV-19 (AZD12222) (Oxford, AstaZeneca) vaccination program was implemented in parallel with the BNT162b2 vaccination program In the COVEMUZ-2 study the investigators have already started to document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using BNT162b2) in the UZ Brussels. In this study, the investigators aim to prospectively document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees (using ChAdOx1 nCoV-19) of the UZ Brussel, at three different time points, namely 6 weeks (+/- 2 weeks; T1), 6 months (+/- 1 month; T2) and 12 months (+/- 1 month; T3) after the second vaccination.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSerological testingAntibody testing for Sars-CoV-2 specific antibodies in blood + T cell immunity

Timeline

Start date
2021-05-05
Primary completion
2028-05-01
Completion
2028-06-01
First posted
2021-06-25
Last updated
2025-12-18

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04939402. Inclusion in this directory is not an endorsement.