SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following COVID-19 Vaccination Using an Adenoviral Vector
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Seroprevalence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any adult employee of the UZ Brussel at T1 who has been vaccinated at the UZ Brussel with ChAdOx1 nCoV-19 vaccine between the 2nd of March and the 9th of March 2021 after participating to phase 4 of the COVEMUZ study between the 25th of January and the 12th of February and has provided a signed informed consent.
排除标准
- •UZ Brussel employees not active during the inclusion period (T1).
结局指标
主要结局
Seroprevalence
时间窗: Change from baseline to 8 weeks, 6 months and 12 months timepoint
To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel after ChAdOx1 nCoV-19 vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies
Seroconversion
时间窗: Change from baseline to 8 weeks, 6 months and 12 months timepoint
To document SARS-CoV-2 seroconversion among employees of the UZ Brussel after ChAdOx1 nCoV-19 vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies
次要结局
- SARS-CoV-2 seroprevalence before and after vaccination(Change from baseline to 8 weeks, 6 months and 12 months timepoint)
- incidence of new definite cases(Change from baseline to 8 weeks, 6 months and 12 months timepoint)
- incidence of new probable cases(Change from baseline to 8 weeks, 6 months and 12 months timepoint)
- antigen-specificity of the SARS-CoV-2-specific T cells(Change from baseline to 8 weeks, 6 months and 12 months timepoint)
- antibody neutralisation capacity of the SARS-CoV-2 specific B cells using immunassays(Change from baseline to 8 weeks, 6 months and 12 months timepoint)
- antibody kinetics of the SARS-CoV-2 specific antibodies using immunassays(Change from baseline to 8 weeks, 6 months and 12 months timepoint)