Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment

Healthy Subjects Clinical Trial

— MI-V3  

Official title:

Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381857
• Other study ID #: 2020-062
• Status: Completed
• Start date: March 15, 2022
• Est. completion date: October 13, 2022

Study information

• Verified date: July 2023
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Human Biological Samples
Blood, urine, nasal swab, fecal samples

Locations

Country	Name	City	State
France	Biotrial	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Country where clinical trial is conducted

France, 

References & Publications (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. — View 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. Erratum In: Nat Immunol. 2018 May 3;: — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify associations with immune response variability	Identifying factors (genetic, epigenetic, immunological and environmental) that contributes to the observed heterogeneity in immune responses at the individual and population level over time	20 years

External Links

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