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

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

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Key information

Conditions

Healthy Subjects

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biotrial

Rennes, 35042, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human biological samples

Other

Blood, urine, nasal swab, fecal samples

Primary outcomes

Identify associations with immune response variability

Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Registry information

Acronym: MI-V3

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: May 19, 2022
Registry last updated: Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed