Longitudinal Follow-up of SARS-CoV-2 (COVID-19) Immunity in Immunocompromised Populations in Belgium (COVICO) in Nursing Home Residents and Staff During the Winter Season 2022-2023
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Concentration of SARS-CoV-2 binding and neutralizing antibodies
研究概览
简要总结
The immune response of COVID-19 vaccination was monitored and studied in the context of the previously PICOV study (P2020/424), Nephro- VAC studies (P2020/284 and P2020/312) and Lung-VAC study (P2021/182). The constant emergence of new variants of concern (VOCs), which become increasingly better at escaping infection and vaccine induced immune responses, together with waning immunity over time, warrant additional vaccination rounds. This is especially true in immunocompromised populations.
In the current study, we want to continue monitoring SARS-CoV-2 specific immunity over the next two years, encompassing several future vaccination campaigns.
详细描述
Background: In collaboration with several Belgian universities, hospitals and institutes, Sciensano, the Belgian Scientific Institute of Public Health, set up a consortium to facilitate and streamline the organization of COVID-19 vaccination studies primarily in immunocompromised populations. The immune response of COVID-19 vaccination was monitored and studied in the context of the previously PICOV study (P2020/424), Nephro- VAC studies (P2020/284 and P2020/312) and Lung-VAC study (P2021/182). The constant emergence of new variants of concern (VOCs), which become increasingly better at escaping infection and vaccine induced immune responses, together with waning immunity over time, warrant additional vaccination rounds. This is especially true in immunocompromised populations.
In the current study, we want to continue monitoring SARS-CoV-2 specific immunity over the next two years, encompassing several future vaccination campaigns.
Method: A non-commercial multicenter academic prospective cohort study will be conducted in immunocompromised populations and healthy adults for two years. These healthy people will be recruited from the previously organized PICOV-VAC study (members of nursing home staff) (EudraCT 2021-000401-24) and REDU-VAC study (EudraCT 2021-002088-23) while the immunocompromised participants will be recruited from the previously established PICOV-VAC, REDU-VAC, Lung-VAC and Nephro-VAC cohorts from which historic clinic and immunologic data is available. Participants will be sampled three times a year independently of the vaccinations which will be administered through regular channels not linked to the study itself.
Objectives: The main goal of this study is to measure levels of immunity in healthy adults and immunocompromised participants three times a year. The primary objective is to determine binding and neutralizing antibody levels against the epidemiologically predominant SARS- CoV-2 variants of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain). This will allow us to determine to which extent extra booster doses can or cannot induce more (binding) and/or better (neutralizing) antibodies to different variants as compared to peak responses achieved after previous vaccination doses and to study waning of these responses after winter periods.
Secondary objectives include studying the vaccine induced immunity in more detail. This includes the further characterization of the quality of the antibody response and the measurement of the cellular immune response, amongst others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Being a resident or member of staff in a nursing home and having participated in the previously organized PICOV-VAC study.
- •Being cognitively capable to give consent to participate in the study.
- •Being a healthy adults and having participated in the previous REDU-VAC study
- •Being a kidney transplant or dialysis patient and having participated in the previous NEPHRO-VAC study
- •Being a lung transplant patient and having participated in the previous LUNG-VAC study
排除标准
- •Having insufficient knowledge of the Dutch or French language..
- •Having a previous diagnosis of dementia and/or having a mini-mental state examination (MMSE) score < 18/
- •Having veins which are not accessible for simple peripheral blood puncture.
结局指标
主要结局
Concentration of SARS-CoV-2 binding and neutralizing antibodies
时间窗: Three times a year, during two years
change in the concentration of binding and neutralizing antibodies against the epidemiologically predominant SARS-CoV-2 variant of concern (VOC) and the wild type SARS-CoV-2 (Wuhan strain)
次要结局
- Levels of non-neutralizing functions of antibodies to SARS-CoV-2(Three times a year, during two years)
- Levels of mucosal antibodies to SARS-CoV-2(Three times a year, during two years)
- Maturation of specific antibody affinity to SARS-CoV-2(Three times a year, during two years)
- Frequencies of T and B cell to SARS-CoV-2(Three times a year, during two years)
研究者
Maria Goossens
Coordinator observational trial unit
Sciensano