此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff (COVIDIM)

2021年5月21日 更新者：University Hospital, Clermont-Ferrand

Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Immunogenicity data demonstrate that they induce the development of neutralizing antibodies and IgG directed against the viral S1 protein and the receptor binding domain (RBD). However, there are currently no data on the persistence over time of the humoral response induced by vaccination, and data are still incomplete on cellular immunogenicity. No immune correlate of protection has been established for COVID-19.

In addition, these data come from assays carried out with current vaccines developed against a lineage of SARS-CoV-2 known as wild type (without genetic mutations).

The main objective of this study is to monitor in hospital staff the temporal evolution of humoral immunity induced by anti-COVID-19 vaccines by using enzyme-linked immunosorbent assays (ELISA), at 3, 6, 12 and 24 months after the last injection of vaccine.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

  • All medical, para-medical, medico-technical and administrative staff of the Clermont-Ferrand university hospital will be informed of the protocol through intra-hospital communication. The inclusion visit will be scheduled within 3 months +/- 14 days after the last injection of the vaccine. For volunteers who have not received their first injection, they will be offered to participate in the sub-study including an additional visit on the day of vaccination. They will be free to accept or refuse.
  • As recruitment is consecutive, an anonymous list of potentially eligible subjects (with demographic data: age, sex; nature of the vaccine received) will be kept, in order to verify afterwards if the sample is representative.

  • The study includes:

    1. Five visits over 21 months, 6 over 24 months for the subgroup included on the day of vaccination
    2. An interview with an investigator during the first visit, to collect the following data: hospital function, age, sex, weight, height, possible comorbidities exposing to a serious COVID-19 infection, possible COVID-19 infection prior to vaccination, date of vaccination and type of vaccine
    3. A self-questionnaire to update clinical data if necessary during the following visits

    4. A blood test at each visit, i.e. 2 tubes of 5 mL (antibody assays) and 4 tubes of 1 mL (cellular immunity assay).

      Blood samples will be stored at -80°C, before destruction at the end of the study.

  • In the case of suspecting symptoms of COVID-19 during follow-up, molecular testing of SARS-CoV-2 infection will be offered and performed from nasopharyngeal swab or saliva sample.

研究类型

介入性

注册 (预期的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
    • Aura
      • Clermont-Ferrand、Aura、法国、63000
        • 招聘中
        • Clermont-Ferrand University Hospital
        • 首席研究员：
          • Cécile Henquell

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult person, man or woman, staff of the Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), having received the second dose of vaccine (or the single dose if the single-dose vaccination schedule) against COVID- 19 3 months +/- 15 days before the inclusion visit, as part of the national vaccination campaign, regardless of the type of vaccine administered.
  • For the subgroup included before vaccination (study of the pre-vaccination cellular response): Adult person, man or woman, staff of Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), receiving the 1st injection on the same day or in the 7 days before the inclusion visit, regardless of the type of vaccine administered
  • Commitment to respect the schedule of visits provided for in the research protocol
  • Able to give informed consent to participate in research
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Pregnancy or breastfeeding in progress at inclusion, or planned during follow-up
  • Person under guardianship, guardianship or legal protection
  • Whether the vaccine received was experimental or not authorized
  • Refusal of participation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Monitoring of the immune response
Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months
生物：Monitoring of the immune response
Blood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
the blood level of anti-S1 / RBD antibodies
大体时间：3 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
3 months
the blood level of anti-S1 / RBD antibodies
大体时间：6 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
6 months
the blood level of anti-S1 / RBD antibodies
大体时间：12 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
12 months
the blood level of anti-S1 / RBD antibodies
大体时间：24 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
24 months

次要结果测量

结果测量
措施说明
大体时间
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
大体时间：3 months, 6 months, 12 months, 18 months, 24 months
Comparison of the humoral response evaluated by serological tests with that analysed by neutralisation in vitro, on pairs of samples chosen to cover the variability of the response induced by vaccination between M3 and M24.
3 months, 6 months, 12 months, 18 months, 24 months
anti-S lymphocyte response induced by the anti-COVID-19 vaccine
大体时间：3 months, 6 months, 12 months, 18 months, 24 months
Cellular immune response induced by the anti-COVID-19 vaccine evaluated by the anti-S lymphocyte response reflected by the determination of IFN-γ at the 3rd, 6th, 12th, 18th and 24th months after the second injection of vaccine (or the single injection if scheme single dose vaccine).
3 months, 6 months, 12 months, 18 months, 24 months
effect of age on immune response
大体时间：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of age on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to different comorbidities
大体时间：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of comorbidities on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to a previous COVID-19 infection or not
大体时间：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of a previous COVID-19 infection on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to the type of vaccine administered
大体时间：3 months, 6 months, 12 months, 18 months, 24 months
Study the effect of the type of vaccine administered on the various immune parameters studied, in general and in their temporal course
3 months, 6 months, 12 months, 18 months, 24 months
the cellular immune response directed against the Spike peptides of T lymphocytes before vaccination, between D-7 and the day of the 1st injection of vaccine
大体时间：Day 1
Pre-vaccine anti-S cellular immune response reflected by the IFN-γ assay, for a subgroup of 50 volunteers then benefiting from the same follow-up until the 24th month
Day 1
genomic characteristics of the strain of SARS-CoV-2 in case of proven COVID-19 infection during follow-up
大体时间：up to 24 months
Clinical description of subjects presenting with COVID-19 infection during follow-up, and genomic characteristics of their strain of SARS-CoV-2 by whole genome sequencing (next-generation sequencing).
up to 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Clermont-Ferrand

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月19日

初级完成 (预期的)

2023年11月1日

研究完成 (预期的)

2024年5月1日

研究注册日期

首次提交

2021年5月18日

首先提交符合 QC 标准的

2021年5月19日

首次发布 (实际的)

2021年5月21日

研究记录更新

最后更新发布 (实际的)

2021年5月24日

上次提交的符合 QC 标准的更新

2021年5月21日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RBHP 2021 HENQUELL

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Monitoring of the immune response的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Denmark

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅