<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01699893</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00238-35</org_study_id>
    <nct_id>NCT01699893</nct_id>
  </id_info>
  <brief_title>Genetic &amp; Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine</brief_title>
  <acronym>LabExMI</acronym>
  <official_title>Genetic &amp; Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Pasteur</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Pasteur</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the determinants of immunologic variance within the&#xD;
      general healthy population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Susceptibility to infections, disease severity, and response to medical therapies and&#xD;
      vaccines are highly variable from one individual to another. While the question of variance&#xD;
      in human populations continues to be a focal point of scientific research, medical practices&#xD;
      and public health policies typically take a 'one size fits all' model to disease management&#xD;
      and drug development.&#xD;
&#xD;
      Individual heterogeneity in the immune response can have an enormous impact on the likelihood&#xD;
      to respond to therapy or the development of side effects secondary to vaccine administration.&#xD;
      Because of the complexity of immune responses in the individual and within the population, it&#xD;
      has not been possible thus far to define the parameters (genetic or environmental) that&#xD;
      constitute a healthy immune system and its natural occurring variability.&#xD;
&#xD;
      Efforts to restore the 'personal' in medical care are the current challenge, and the driving&#xD;
      vision of the project, to which the current study belongs.&#xD;
&#xD;
      In order to realize the promise of personalized medicine, an in-depth understanding of the&#xD;
      determinants of heterogeneity in host response to stress is required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of cytokine/chemokine stimulated by 40 pattern-recognition receptors agonists (PRR agonists) or immune stimulators.</measure>
    <time_frame>V2 (28days after V1)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of genotype-to-phenotype associations at a mechanistic level</measure>
    <time_frame>4 days after V0</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1012</enrollment>
  <condition>Individuality</condition>
  <arm_group>
    <arm_group_label>unique arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At V0: 1500 will be screened&#xD;
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)&#xD;
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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>unique arm</intervention_name>
    <description>blood, nasal swab, skin biopsy, stool samples</description>
    <arm_group_label>unique arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects considered as healthy by the investigator based on medical history, clinical&#xD;
             examination, laboratory results and ECG (blood sampling for laboratory assessments and&#xD;
             ECG should be done at V0 and only after signed informed consent).&#xD;
&#xD;
          2. Subjects who, according to the investigator, can and will comply with the requirements&#xD;
             of the protocol and are available for all scheduled visits at the investigational&#xD;
             site.&#xD;
&#xD;
          3. Healthy male or female aged between 20 and 69 (included) years&#xD;
&#xD;
          4. Metropolitan French origin for 3 generations 5)18.5 ≤BMI ≤ 32 kg/m² (Appendix 18.6)&#xD;
&#xD;
        6)Ability to give their informed consent in writing 7)Must understand spoken and written&#xD;
        French 8)Affiliated to the French social security or assimilated regimens 9)Registered on&#xD;
        the French &quot;Fichier des Volontaires se prêtant à la Recherche Biomédicale (VRB)&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who can not participate according to their status on the registry mentioned&#xD;
             at Art L. 1121-16 of the French Public Health Code&#xD;
&#xD;
          2. Participation in another clinical study in the last 3 months in which the subject has&#xD;
             been exposed to an investigational product (pharmaceutical product or placebo or&#xD;
             medical device) or concurrent participation in another clinical study during the study&#xD;
             period&#xD;
&#xD;
          3. Relatedness to previously recruited individuals in the study cohort&#xD;
&#xD;
          4. Travel in (sub-)tropical countries within the last 3 months&#xD;
&#xD;
          5. For women: pregnant or breastfeeding or intending to become pregnant or&#xD;
             peri-menopausal*&#xD;
&#xD;
             * Peri-menopausal women as defined by menstrual irregularity: either a change in the&#xD;
             menstrual cycle length of more than seven days (early perimenopause) or two or more&#xD;
             missed periods with an interval of 60 days or more between periods (late&#xD;
             perimenopause) (Stages of Reproductive Aging Workshop, STRAW)(11)&#xD;
&#xD;
          6. Any physical exercise within the last 8 hours before inclusion (V1) and before (V2)&#xD;
&#xD;
          7. Subjects following a special diet for medical reasons as prescribed by a GP or&#xD;
             dietician (e.g. calorie restricted or weight-loss diet for significant overweight,&#xD;
             cholesterol lowering diet or subjects suffering from any clinically diagnosed food&#xD;
             allergy or intolerance)&#xD;
&#xD;
          8. Alcohol abuse (more than 50 g of pure ethanol per day: for example, more than 4 x 150&#xD;
             mL glasses of wine, more than 4 x 250 mL glasses of beer, more than 4 x 40 mL glasses&#xD;
             of high alcohol content drinks)&#xD;
&#xD;
          9. Illicit drug use or substance abuse within 3 months prior to inclusion&#xD;
&#xD;
         10. Presence of evidence of neurological or psychiatric diagnoses which, although stable,&#xD;
             are deemed by the investigator to render the potential subject unable/unlikely to&#xD;
             participate in the study satisfactorily.&#xD;
&#xD;
         11. Severe/chronic/recurrent pathological conditions,&#xD;
&#xD;
         12. Chronic administration (defined as more than 14 days) of immunosuppressants or other&#xD;
             immune-modifying drugs within the 6 months prior to the inclusion. For&#xD;
             corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or&#xD;
             equivalent for &gt; 2 weeks (inhaled and topical steroids allowed)&#xD;
&#xD;
         13. Chronic administration of NSAIDs, including aspirin: prolonged intake (&gt; 2 weeks)&#xD;
             within 6 months before study or any intake within the 7 days preceding skin biopsy&#xD;
             [exception for low dose aspirin: maximum 250mg/daily, see 8.1]&#xD;
&#xD;
         14. Receipt of any vaccination 3 months before the inclusion or planning to receive any&#xD;
             vaccination during the study&#xD;
&#xD;
         15. Receipt of blood products or immunoglobulins within 3 months prior the inclusion or&#xD;
             planning to receive blood products or immunoglobulins during the study&#xD;
&#xD;
         16. Hemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men&#xD;
&#xD;
         17. Platelet count less than 120.000/mm3&#xD;
&#xD;
         18. ALAT and/or ASAT &gt; 3 times the upper limit of the norm (ULN)&#xD;
&#xD;
         19. Allergy to lidocaine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew ALBERT</last_name>
    <role>Study Chair</role>
    <affiliation>Institut Pasteur / Inserm</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lluis QUINTANA-MURCI</last_name>
    <role>Study Chair</role>
    <affiliation>Institut Pasteur / CNRS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolas FAUCHOUX</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biotrial Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BIOTRIAL</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699893
org study id: 2012-A00238-35
nct id: NCT01699893
lead sponsor: 
has dmc: No
The purpose of this study is to assess the determinants of immunologic variance within the
      general healthy population.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Measurement of cytokine/chemokine stimulated by 40 pattern-recognition receptors agonists (PRR agonists) or immune stimulators.
time frame: V2 (28days after V1)
measure: Determination of genotype-to-phenotype associations at a mechanistic level
time frame: 4 days after V0
arm group label: unique arm
arm group type: Experimental
description: 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
intervention type: Other
intervention name: unique arm
description: blood, nasal swab, skin biopsy, stool samples
arm group label: unique arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew ALBERT
role: Study Chair
affiliation: Institut Pasteur / Inserm
last name: Lluis QUINTANA-MURCI
role: Study Chair
affiliation: Institut Pasteur / CNRS
last name: Nicolas FAUCHOUX
role: Principal Investigator
affiliation: Biotrial Rennes
facility: 
country: France
responsible party type: Sponsor