跳至主要内容
临床试验/NCT04644159
NCT04644159已完成不适用

Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation in Early 2020

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
2
主要终点
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.

研究概览

简要总结

An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

The goal of this new project is to better characterize the specific immunity generated by the infection within this community. The specific immune response to the SARS-CoV-2 virus will be followed for a period of 2 years from the initial circulation of the virus, within a large cohort of participants covering all age groups from 5 years-old onwards. The study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. Follow-up of participants in this cohort and monitoring of the virus circulation within this community would help to determine the protective character against re-infection of the natural immunity generated by SARS-CoV-2.

详细描述

An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

These surveys have documented the circulation of SARS-CoV-2 in one of the first French COVID-19 outbreaks and this study proposes to better characterize the specific immunity generated by the infection among this community. Indeed, the nature of this immunity and its persistence over time are crucial information. The goal of this new project is to explore the specific immune response to the SARS CoV 2 virus for a period of 2 years from the initial circulation of the virus in this north of France city, within a large cohort of participants in the general population covering all age groups from 5 years of age but also in patients and residents of retirement homes in this city. It is expected that the immune response conferred by natural infection or vaccination will differ according to age.

This study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. The genetic basis of the diversity of humoral responses induced by SARS-CoV-2 and those related to the multiplicity of clinical manifestations of COVID-19 will also be investigated. This would provide initial evidence to determine the protective character against re-infection of the natural immunity generated by CoV-2-SARS. Finally, these data will be used to model the intra-family transmission of the virus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adultes and minors from 5 years old
  • Affiliated with or benefiting from a Social Security system
  • State of health compatible with a blood sample as defined in the protocol

排除标准

  • Person benefiting from a legal protection measure or unable to express informed consent to participation and for which the legal representative or tutor person could not be contacted.

结局指标

主要结局

Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.

时间窗: 2 years

Description of the serological status of individuals

次要结局

  • Presence of specific T cell response to the SARS-CoV-2(2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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