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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Criteria

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

Contacts and Locations

Locations

France

Biotrial

Rennes, France, 35042

Sponsors and Collaborators

Institut Pasteur

Investigators

• Study Director: Lluis QUINTANA MURCI, PhD; Institut Pasteur

More Information

Additional Information:

The website provides a description of the Milieu Intérieur project, consortium and collaborative studies 

Publications:

Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. The Milieu Interieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.

Duffy D, Rouilly V, Libri V, Hasan M, Beitz B, David M, Urrutia A, Bisiaux A, Labrie ST, Dubois A, Boneca IG, Delval C, Thomas S, Rogge L, Schmolz M, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Functional analysis via standardized whole-blood stimulation systems defines the boundaries of a healthy immune response to complex stimuli. Immunity. 2014 Mar 20;40(3):436-50. doi: 10.1016/j.immuni.2014.03.002.

Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jonsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Mar;19(3):302-314. doi: 10.1038/s41590-018-0049-7. Epub 2018 Feb 23. Erratum In: Nat Immunol. 2018 May 3;:

• Responsible Party: Institut Pasteur
• ClinicalTrials.gov Identifier: NCT05381857
• Other Study ID Numbers: 2020-062
• First Posted: May 19, 2022
• Last Update Posted: October 31, 2022
• Last Verified: February 2022

• 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