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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05381857
Acronym
MI-V3
Enrollment
415
Registered
2022-05-19
Start date
2022-03-15
Completion date
2022-10-13
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Immune response, Immune system, genotype-to-phenotype association, genetic variability, reference-based population

Brief summary

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

Detailed description

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.

Interventions

Blood, urine, nasal swab, fecal samples

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Identify associations with immune response variability20 yearsIdentifying factors (genetic, epigenetic, immunological and environmental) that contributes to the observed heterogeneity in immune responses at the individual and population level over time

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026