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临床试验/NCT05381857
NCT05381857已完成不适用

Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment

Institut Pasteur1 个研究点 分布在 1 个国家目标入组 415 人开始时间: 2022年3月15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
415
试验地点
1
主要终点
Identify associations with immune response variability

研究概览

简要总结

Effects of aging, genetics and environmental exposures on immune variation in a previously well-defined healthy population (NCT03905993).

详细描述

Susceptibility to infections, disease severity, and response to medical therapies and vaccines are highly variable from one individual to another.

Individual heterogeneity in the immune response can have an enormous impact on the likelihood to respond to therapy or the development of side effects secondary to vaccine administration. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that constitute a healthy immune system and its natural occurring variability.

The overall aim of the Milieu Intérieur study (NCT03905993) is to define the parameters that characterise a healthy immune response and its natural variation across individuals, and in doing so, inform clinical strategies for managing disease. To achieve this, in 2012, a total of 1000 healthy volunteers, descendants of mainland French persons for at least three generations, split equally by sex (1:1 sex ratio) and stratified across five-decades of life were recruited.

With the first data collection (clinical study), key fundamental insights were gained. The project has also established a rich sample and data repository, supporting ongoing integrative research in systems immunology and personalized medicine.

To provide a longitudinal assessment of the immune variation observed in the Milieu Intérieur cohort, this research aim to perform a follow-up study of the cohort, 10 years after the initial study.

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
30 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any individual that provided samples for the initial Milieu Intérieur study (NCT03905993)
  • Ability to give their informed consent in writing
  • Subjects who, according to the investigator, can and will comply with the requirements of the protocol.
  • Affiliated to the French social security or assimilated regimens

排除标准

  • Individuals benefiting from a legal protection measure
  • Individuals unable to express informed consent for participation
  • Pregnant and breastfeeding women

结局指标

主要结局

Identify associations with immune response variability

时间窗: 20 years

Identifying factors (genetic, epigenetic, immunological and environmental) that contributes to the observed heterogeneity in immune responses at the individual and population level over time

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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