Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment (MI-V3)

Pasteur Institute

Status

Completed

Conditions

Healthy Subjects

Treatments

Other: Human Biological Samples

Study type

Observational

Funder types

Industry

Identifiers

NCT05381857

2020-062

Details and patient eligibility

About

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

Full 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.

Enrollment

415 patients

Sex

All

Ages

30 to 79 years old

Volunteers

Accepts Healthy Volunteers

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