Clinical trial NCT05381857: Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment
Official title: Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Keywords: Immune response
Immune system
genotype-to-phenotype association
genetic variability
reference-based population
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 415
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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

Primary outcomes:
measure: Identify associations with immune response variability
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Biotrial
Study officials:
affiliation: Institut Pasteur
name: Lluis QUINTANA MURCI, PhD
role: STUDY_DIRECTOR
affiliation: Institut Pasteur
name: Darragh DUFFY, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.