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Trial record 1 of 3 for:    Milieu Interieur | France
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Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment (MI-V3)

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ClinicalTrials.gov Identifier: NCT05381857
Recruitment Status : Active, not recruiting
First Posted : May 19, 2022
Last Update Posted : October 31, 2022
Information provided by (Responsible Party):
Institut Pasteur

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

Condition or disease Intervention/treatment
Healthy Subjects Other: Human Biological Samples

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.

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Study Type : Observational
Actual Enrollment : 415 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 30, 2042

Group/Cohort Intervention/treatment
Individual from the initial Milieu Intérieur study
Individual who provided samples for the initial Milieu Intérieur study
Other: Human Biological Samples
Blood, urine, nasal swab, fecal samples

Primary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples With DNA
serum, plasma, urine, nasal swab, fecal samples

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults subjects, aged from 30 to 79 years old that provided samples for the initial Milieu Intérieur study

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381857

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Rennes, France, 35042
Sponsors and Collaborators
Institut Pasteur
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Study Director: Lluis QUINTANA MURCI, PhD Institut Pasteur
Additional Information:
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT05381857    
Other Study ID Numbers: 2020-062
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Immune response
Immune system
genotype-to-phenotype association
genetic variability
reference-based population