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

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

Detailed Description
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Human Biological Samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Individuals benefiting from a legal protection measure Individuals unable to express informed consent for participation Pregnant and breastfeeding women

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individual from the initial Milieu Intérieur study<br>Individual who provided samples for the initial Milieu Intérieur study | Other: Human Biological Samples<br>* Blood, urine, nasal swab, fecal samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify associations with immune response variability | Identifying factors (genetic, epigenetic, immunological and environmental) that contributes to the observed heterogeneity in immune responses at the individual and population level over time | 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune response, Immune system, genotype-to-phenotype association, genetic variability, reference-based population