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
|Condition or disease||Intervention/treatment|
|Healthy Subjects||Other: Human Biological Samples|
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.
|Study Type :||Observational|
|Actual Enrollment :||415 participants|
|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|
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
- 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
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
|Rennes, France, 35042|
|Study Director:||Lluis QUINTANA MURCI, PhD||Institut Pasteur|