Genetic & Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine

NCT01699893 | Completed

• 1 other identifier: 2012-A00238-35
• Study Type: interventional
• Target: 1,012
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the determinants of immunologic variance within the general healthy population.

Conditions

Individuality

Outcome Measures

Primary Outcomes (1)

• Measurement of cytokine/chemokine stimulated by 40 pattern-recognition receptors agonists (PRR agonists) or immune stimulators.

  V2 (28days after V1)

Secondary Outcomes (1)

• Determination of genotype-to-phenotype associations at a mechanistic level

  4 days after V0

Study Arms (1)

unique arm

EXPERIMENTAL

* At V0: 1500 will be screened * At V1: 1000 subjects will be performed following samples: blood, nasal swab,stool. 500 subjects among 1000 will be performed one additional sample (Skin Biopsy) * At V2: only the 500 subjects having performing the skin biopsy at V1 will come at V2 to perform blood, nasal swab and stool samples

Other: unique arm

Interventions

unique arm OTHER

blood, nasal swab, skin biopsy, stool samples

unique arm

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects considered as healthy by the investigator based on medical history, clinical examination, laboratory results and ECG (blood sampling for laboratory assessments and ECG should be done at V0 and only after signed informed consent).
• Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
• Healthy male or female aged between 20 and 69 (included) years
• Metropolitan French origin for 3 generations 5)18.5 ≤BMI ≤ 32 kg/m² (Appendix 18.6)
• )Ability to give their informed consent in writing 7)Must understand spoken and written French 8)Affiliated to the French social security or assimilated regimens 9)Registered on the French "Fichier des Volontaires se prêtant à la Recherche Biomédicale (VRB)"

You may not qualify if:

• Subjects who can not participate according to their status on the registry mentioned at Art L. 1121-16 of the French Public Health Code
• Participation in another clinical study in the last 3 months in which the subject has been exposed to an investigational product (pharmaceutical product or placebo or medical device) or concurrent participation in another clinical study during the study period
• Relatedness to previously recruited individuals in the study cohort
• Travel in (sub-)tropical countries within the last 3 months
• For women: pregnant or breastfeeding or intending to become pregnant or peri-menopausal\*
• \* Peri-menopausal women as defined by menstrual irregularity: either a change in the menstrual cycle length of more than seven days (early perimenopause) or two or more missed periods with an interval of 60 days or more between periods (late perimenopause) (Stages of Reproductive Aging Workshop, STRAW)(11)
• Subjects following a special diet for medical reasons as prescribed by a GP or dietician (e.g. calorie restricted or weight-loss diet for significant overweight, cholesterol lowering diet or subjects suffering from any clinically diagnosed food allergy or intolerance)
• Alcohol abuse (more than 50 g of pure ethanol per day: for example, more than 4 x 150 mL glasses of wine, more than 4 x 250 mL glasses of beer, more than 4 x 40 mL glasses of high alcohol content drinks)
• Presence of evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to participate in the study satisfactorily.
• Severe/chronic/recurrent pathological conditions,
• Chronic administration of NSAIDs, including aspirin: prolonged intake (\> 2 weeks) within 6 months before study or any intake within the 7 days preceding skin biopsy \[exception for low dose aspirin: maximum 250mg/daily, see 8.1\]
• Hemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men
• Platelet count less than 120.000/mm3
• ALAT and/or ASAT \> 3 times the upper limit of the norm (ULN)
• Allergy to lidocaine

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (1)

BIOTRIAL

Rennes, 35042, France

Location

Related Publications (3)

• Scepanovic P, Hodel F, Mondot S, Partula V, Byrd A, Hammer C, Alanio C, Bergstedt J, Patin E, Touvier M, Lantz O, Albert ML, Duffy D, Quintana-Murci L, Fellay J; Milieu Interieur Consortium. A comprehensive assessment of demographic, environmental, and host genetic associations with gut microbiome diversity in healthy individuals. Microbiome. 2019 Sep 13;7(1):130. doi: 10.1186/s40168-019-0747-x.

  PMID: 31519223 DERIVED

• Partula V, Mondot S, Torres MJ, Kesse-Guyot E, Deschasaux M, Assmann K, Latino-Martel P, Buscail C, Julia C, Galan P, Hercberg S, Rouilly V, Thomas S, Quintana-Murci L, Albert ML, Duffy D, Lantz O, Touvier M; Milieu Interieur Consortium. Associations between usual diet and gut microbiota composition: results from the Milieu Interieur cross-sectional study. Am J Clin Nutr. 2019 May 1;109(5):1472-1483. doi: 10.1093/ajcn/nqz029.

  PMID: 31051503 DERIVED

• Scepanovic P, Alanio C, Hammer C, Hodel F, Bergstedt J, Patin E, Thorball CW, Chaturvedi N, Charbit B, Abel L, Quintana-Murci L, Duffy D, Albert ML, Fellay J; Milieu Interieur Consortium. Human genetic variants and age are the strongest predictors of humoral immune responses to common pathogens and vaccines. Genome Med. 2018 Jul 27;10(1):59. doi: 10.1186/s13073-018-0568-8.

  PMID: 30053915 DERIVED

Study Officials

• Matthew ALBERT

  Institut Pasteur / Inserm

  STUDY CHAIR

• Lluis QUINTANA-MURCI

  Institut Pasteur / CNRS

  STUDY CHAIR

• Nicolas FAUCHOUX

  Biotrial Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 4, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

FR (1)