AzTrials
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IndividualityLabExMINCT01699893

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

A study testing unique arm in people with Individuality, run by Institut Pasteur at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Individuality
What is being tested?
unique arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,012 participants
Where
1 siteFrance
Study dates
Sep 2012to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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)"

Who cannot join

  • 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)
Show all 20Show fewer
  • Any physical exercise within the last 8 hours before inclusion (V1) and before (V2)
  • 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)
  • Illicit drug use or substance abuse within 3 months prior to inclusion
  • 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months prior to the inclusion. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for > 2 weeks (inhaled and topical steroids allowed)
  • 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]
  • Receipt of any vaccination 3 months before the inclusion or planning to receive any vaccination during the study
  • Receipt of blood products or immunoglobulins within 3 months prior the inclusion or planning to receive blood products or immunoglobulins during the study
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • BIOTRIAL

    Rennes, 35042

Other trials in France

About this study

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

Read the detailed description

Susceptibility to infections, disease severity, and response to medical therapies and vaccines are highly variable from one individual to another. While the question of variance in human populations continues to be a focal point of scientific research, medical practices and public health policies typically take a 'one size fits all' model to disease management and drug development.

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.

Efforts to restore the 'personal' in medical care are the current challenge, and the driving vision of the project, to which the current study belongs.

In order to realize the promise of personalized medicine, an in-depth understanding of the determinants of heterogeneity in host response to stress is required.

Conditions
Individuality
Being tested
unique arm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • unique armOther

    blood, nasal swab, skin biopsy, stool samples

Study groups in NCT01699893
Study groupRoleWhat they receive
unique armExperimental* 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
Receives: Other: unique arm

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: V2 (28days after V1)

Secondary outcomes (1)

  1. Determination of genotype-to-phenotype associations at a mechanistic level

    Measured: 4 days after V0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,012 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01699893
Sponsor's protocol ID
2012-A00238-35
Acronym
LabExMI
Status last verified
May 2015
First submitted
21 Sep 2012
Last updated
29 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Saint-Andre V, Charbit B, Biton A, Rouilly V, Posseme C, Bertrand A, Rotival M, Bergstedt J, Patin E, Albert ML, Quintana-Murci L, Duffy D; Milieu Interieur Consortium. Smoking changes adaptive immunity with persistent effects. Nature. 2024 Feb;626(8000):827-835. doi: 10.1038/s41586-023-06968-8. Epub 2024 Feb 14.

    PubMed 38355791

  • 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.

    PubMed 31519223

  • 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.

    PubMed 31051503

  • 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.

    PubMed 30053915

Questions about this trial

What is this clinical trial studying?

A study testing unique arm in people with Individuality, run by Institut Pasteur at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of cytokine/chemokine stimulated by 40 pattern-recognition receptors agonists (PRR agonists) or immune stimulators. (time frame: V2 (28days after V1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01699893, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.

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