<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/NCT01715103</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS VEP1</org_study_id>
    <secondary_id>MUCOVAC</secondary_id>
    <nct_id>NCT01715103</nct_id>
  </id_info>
  <brief_title>Study of Immunity at the Genital Mucosa of HIV-1 Infected and Healthy Women</brief_title>
  <acronym>MUCOVAC</acronym>
  <official_title>Study of Immunity at the Genital Mucosa of HIV-1 Infected and Healthy Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ANRS, Emerging Infectious Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current knowledge on mucosa, especially genitals in women, however, remain inadequate,&#xD;
      especially regarding defense mechanisms and possibilities for a vaccine to induce an active&#xD;
      immune response at mucosal front door of the most pathogens. Induction of mucosal immune&#xD;
      response has emerged as a research priority research prophylactic vaccine.The development of&#xD;
      strategies to prevent sexual transmission of HIV-1 depends in part on an understanding of&#xD;
      specific and innate immune mechanisms involved in this transmission.&#xD;
&#xD;
      MUCOVAC is a feasibility study of the immunological and transcriptomic analysis of&#xD;
      cervicovaginal samples of women infected or not infected with HIV-1. We also assess tolerance&#xD;
      samples taken by cytobrush and cervicovaginal washings, efficiency and reproducibility of the&#xD;
      sample by cytobrush and cervicovaginal lavage for transcriptomic analysis, measurement of&#xD;
      cytokines by Luminex technology, quantification of IgG and IgA. In blood we will determine&#xD;
      the phenotype of B cells and Tfh cell frequency (T follicular helper) and quantification of&#xD;
      serum immunoglobulins and will perform a transcriptomic analysis of blood cells. Finally we&#xD;
      will make correlations with the observed responses at the genital mucosa.&#xD;
&#xD;
      This pathophysiological exploratory study will be performed in 20 women infected with HIV-1&#xD;
      and 20 healthy women recruited from two centers in France and will include a screening visit&#xD;
      and two visits M0 and M1 during which mucous and blood samples will be performed.&#xD;
&#xD;
      The results of the study will capitalize skills in biology mucosa, using powerful tools to&#xD;
      assess mucosal immunological parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eighty-five percent of new cases of HIV infection involve the South and the mode of&#xD;
      transmission is predominantly heterosexual. In northern countries, sexual transmission is&#xD;
      also majority. These epidemiological considerations clearly indicate that HIV is mainly&#xD;
      transmitted mucosally.&#xD;
&#xD;
      Clinical observations show that some people are &quot;resistant&quot; to HIV, ie they do not become&#xD;
      infected despite repeated sexual exposure to the virus. The &quot;resistance&quot; to HIV exposed but&#xD;
      uninfected partners may be due to the absence of infection of target cells in the mucosa of&#xD;
      the host, or to elimination of HIV or of infected cell during effective infection. Biological&#xD;
      factors that govern individual resistance to HIV remain poorly understood. An immune response&#xD;
      directed against cervicovaginal HIV antigens, including viral envelope glycoproteins has been&#xD;
      described in a small number of HIV-negative women sexually exposed to the virus and resistant&#xD;
      to infection. These observations demonstrate that there is a compartmentalization of the&#xD;
      mucosal immune response of women, which can be induced against HIV antigens independently of&#xD;
      systemic humoral immunity. In addition, a cytotoxic cervicovaginal immunity against HIV has&#xD;
      been shown in some women, suggesting that viral antigens are presented to the immune system&#xD;
      in a HLA-I, and therefore that HIV antigens were able to cross the mucosal barrier. A second&#xD;
      hypothesis, which does not exclude the first, is that an immune response can be induced by&#xD;
      repeated deposition of viral antigens on the cervicovaginal mucosa. It has been shown in HEPS&#xD;
      women (Highly sexually exposed to HIV-1 persistently IgG seronegative purpose) the existence&#xD;
      of IgA antibodies directed against gp41 can inhibit both the transcytosis of the virus&#xD;
      through a monolayer epithelial cells and to neutralize the infection of CD4 T cells in vitro.&#xD;
&#xD;
      Soluble factors also play an important role in mucosal transmission of HIV. Indeed,&#xD;
      lymphokines RANTES, MIP-1a and MIP-1b, SDF-1 natural ligands of HIV co-receptors are found in&#xD;
      varying concentrations in vaginal secretions. More recently, it has been shown that the&#xD;
      CCL20/MIP3alpha, which is produced by epithelial cells genital HIV could interact with X4-and&#xD;
      R5-tropic to inhibit infection.&#xD;
&#xD;
      The most common techniques used to study the immunological and microbiological factors of&#xD;
      female genital tract are cervicovaginal lavage (CVL) and swabbing the cervix. As part of a&#xD;
      comprehensive approach to different aspects of mucosal immunity, it is necessary to use&#xD;
      techniques for the acquisition of a large number of information while using small amounts of&#xD;
      samples. Thus, techniques such as transcriptomic analysis on microarrays, which can tell us&#xD;
      about changes in thousands of genes, and the use of techniques for multiplex quantification&#xD;
      of soluble factors (cytokines and soluble factors of immunity innate mucosal) must be&#xD;
      adapted, tested and validated before the start of a vaccine trial so that the samples needed&#xD;
      for immunological assessment be exploited optimally.&#xD;
&#xD;
      A first phase I trial (ANRS VAC14) evaluating the safety and immunogenicity in mucosal and&#xD;
      systemic recombinant gp160 protein oligomeric administered nasally or vaginally with or&#xD;
      without adjuvant (DC-Chol), was performed in women seronegative for HIV. The goal was to&#xD;
      induce secretory IgA (SIgA) level specific genital mucosa. In this study, the storage&#xD;
      conditions of the supernatants of cervicovaginal secretions and cells were not optimal for a&#xD;
      study of the transcriptome. However, on a few samples we have shown the feasibility of&#xD;
      transcriptomic analysis using Illumina technology. We were able on these samples to determine&#xD;
      the profiles of mRNA expression and cytokine profiles. These preliminary results led us to&#xD;
      propose for the new study, to preserve RNA, cell pellets treated with buffer RLT+ Qiagen&#xD;
      before freezing at -80 °C. In addition, protease inhibitors are added directly into the&#xD;
      washing liquid to preserve cervicovaginal immunoglobulins and cytokines degradation.&#xD;
&#xD;
      We propose here a feasibility study of the immunological and transcriptomic analysis of&#xD;
      cervicovaginal samples of women infected or not infected with HIV-1. Secondarily we assess&#xD;
      tolerance samples taken by cytobrush and cervicovaginal washings, efficiency and&#xD;
      reproducibility of the sample by cytobrush and cervicovaginal lavage for transcriptomic&#xD;
      analysis, measurement of cytokines by Luminex technology, quantification of IgG and IgA. In&#xD;
      blood we will determine the phenotype of B cells and Tfh cell frequency (T follicular helper)&#xD;
      and quantification of serum immunoglobulins and will perform a transcriptomic analysis of&#xD;
      blood cells. Finally we will make correlations with the observed responses at the genital&#xD;
      mucosa.&#xD;
&#xD;
      This pathophysiological exploratory study will be performed in 20 women infected with HIV-1&#xD;
      and 20 healthy women recruited from two centers in France and will include a screening visit&#xD;
      and two visits M0 and M1 during which mucous and blood samples will be performed.&#xD;
&#xD;
      The results of the study will capitalize skills in biology mucosa, using powerful tools to&#xD;
      assess mucosal immunological parameters. These standardized tools can be used both for the&#xD;
      evaluation of mucosal immune response induced by prototype vaccines, and cohort studies to&#xD;
      search for correlates of protection. These tools can also be used in the evaluation of the&#xD;
      local tolerance to the application of molecules with microbicides.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Results of primary outcome are not satisfactory in terms of RNA quality&#xD;
  </why_stopped>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability, tolerance, Efficiency</measure>
    <time_frame>2 months</time_frame>
    <description>Acceptability&#xD;
Local tolerance of sampling (particularly for collection by cytobrush), bleeding (need for protection, abundance, frequency) leucorrhoea (frequency, amount, aspect), fever, pain, gynecological vaginal burns and general tolerance (fever, occurrence of pelvic infection).&#xD;
Efficiency of collection by washing (Ig rate &gt; 1μg/ml) and quality of cells collected by cytobrush and of cell pellet from washes for a transcriptomic analysis (the quantity and quality of RNA: RIN (RNA integrity number) &gt; 5 and an amount of RNA 50&gt; ng)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of antibodies in cervicovaginal samples</measure>
    <time_frame>Month 0 and month 1</time_frame>
    <description>Concentration of antibodies in cervicovaginal samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of cytokines in cervicovaginal samples</measure>
    <time_frame>month 0 and month 1</time_frame>
    <description>Concentration of cytokines in cervicovaginal samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression genomics in cervicovaginal specimens and whole blood</measure>
    <time_frame>month 0 and month 1</time_frame>
    <description>Expression genomics in cervicovaginal specimens and whole blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B phenotypes and the frequency of Tfh cells in whole blood</measure>
    <time_frame>month 0 and month 1</time_frame>
    <description>B phenotypes and the frequency of Tfh cells in whole blood</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>HIV Infected Women</condition>
  <condition>Healthy Women Volunteers</condition>
  <arm_group>
    <arm_group_label>Healthy women volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy women volunteers with vaginal swabs by washing and cytobrush</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV-1 infected women</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HIV-1 infected women with vaginal swabs by washing and cytobrush</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vaginal swabs by washing and cytobrush</intervention_name>
    <description>vaginal swabs by washing and cytobrush</description>
    <arm_group_label>HIV-1 infected women</arm_group_label>
    <arm_group_label>Healthy women volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Free, informed and signed consent&#xD;
&#xD;
          -  Person affiliated or beneficiary of a social security system or the Universal Health&#xD;
             Coverage&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  No menopausal, aged 18 to 45 years,&#xD;
&#xD;
          -  Under oral contraceptive or implant&#xD;
&#xD;
          -  Urine pregnancy test negative&#xD;
&#xD;
          -  HBsAg and HCV serology negative&#xD;
&#xD;
          -  Cervicovaginal smear normal older than one year,&#xD;
&#xD;
          -  Normal vaginal smear dated within one year&#xD;
&#xD;
        For healthy women&#xD;
&#xD;
        * HIV serology negative&#xD;
&#xD;
        For infected women&#xD;
&#xD;
          -  HIV-1 infection checked by western-blot and/or the detection of HIV-RNA&#xD;
&#xD;
          -  CD4+ T cells &gt;350/mm3 (several tests, since 6 months)&#xD;
&#xD;
          -  Viral load &lt;40 copies/ml since 6 months&#xD;
&#xD;
          -  Treated with antiretroviral drugs since 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history of vaginal pathology (malignancy, prolapse)&#xD;
&#xD;
          -  Hysterectomy, conization&#xD;
&#xD;
          -  History of abnormal Pap smear in the previous year (ASC-US, AG-US and LSIL and high&#xD;
             grade according to Bethesda).&#xD;
&#xD;
          -  Breakthrough bleeding;&#xD;
&#xD;
          -  Clinical symptoms suggestive of genital infection within 10 days prior to the&#xD;
             examination of the study,&#xD;
&#xD;
          -  Antibiotic systemically within 10 days prior to the examination of the study,&#xD;
&#xD;
          -  Immunosuppressive or immunomodulatory treatment in the last six months and&#xD;
             corticosteroids (&gt; 20 mg / day for 5 days) in last 3 months&#xD;
&#xD;
          -  Presence of other sexually transmitted infection detected in samples at pre-inclusion&#xD;
             visit and ongoing at V1 visit (Mycoplasma, Chlamydia, gonorrhea, Trichomonas, Candida&#xD;
             albicans and Syphilis)&#xD;
&#xD;
          -  A person participating in another research including a period of exclusion still&#xD;
             ongoing selection&#xD;
&#xD;
          -  Population called vulnerable (minors, persons under guardianship, or deprived of&#xD;
             liberty by a judicial decision.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fréderic LUCHT, PU PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service des Maladies Infectieuses et Tropicales,CIC-EC, CHU Saint Etienne</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Odile LAUNAY, PU PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre d'investigation clinique Cochin Pasteur (CIC 1417), hôpital Cochin Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre d'investigation clinique Cochin Pasteur (CIC1417)</name>
      <address>
        <city>Paris</city>
        <zip>75 679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service des maladies infectieuses et tropicales</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>June 30, 2015</last_update_submitted>
  <last_update_submitted_qc>June 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV infection</keyword>
  <keyword>mucosa</keyword>
  <keyword>immunological parameters</keyword>
  <keyword>genital sampling</keyword>
  <keyword>healthy women volunteers</keyword>
  <!-- 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/NCT01715103
org study id: ANRS VEP1
secondary id: MUCOVAC
nct id: NCT01715103
lead sponsor: 
has dmc: Yes
Current knowledge on mucosa, especially genitals in women, however, remain inadequate,
      especially regarding defense mechanisms and possibilities for a vaccine to induce an active
      immune response at mucosal front door of the most pathogens. Induction of mucosal immune
      response has emerged as a research priority research prophylactic vaccine.The development of
      strategies to prevent sexual transmission of HIV-1 depends in part on an understanding of
      specific and innate immune mechanisms involved in this transmission.

      MUCOVAC is a feasibility study of the immunological and transcriptomic analysis of
      cervicovaginal samples of women infected or not infected with HIV-1. We also assess tolerance
      samples taken by cytobrush and cervicovaginal washings, efficiency and reproducibility of the
      sample by cytobrush and cervicovaginal lavage for transcriptomic analysis, measurement of
      cytokines by Luminex technology, quantification of IgG and IgA. In blood we will determine
      the phenotype of B cells and Tfh cell frequency (T follicular helper) and quantification of
      serum immunoglobulins and will perform a transcriptomic analysis of blood cells. Finally we
      will make correlations with the observed responses at the genital mucosa.

      This pathophysiological exploratory study will be performed in 20 women infected with HIV-1
      and 20 healthy women recruited from two centers in France and will include a screening visit
      and two visits M0 and M1 during which mucous and blood samples will be performed.

      The results of the study will capitalize skills in biology mucosa, using powerful tools to
      assess mucosal immunological parameters.
Eighty-five percent of new cases of HIV infection involve the South and the mode of
      transmission is predominantly heterosexual. In northern countries, sexual transmission is
      also majority. These epidemiological considerations clearly indicate that HIV is mainly
      transmitted mucosally.

      Clinical observations show that some people are "resistant" to HIV, ie they do not become
      infected despite repeated sexual exposure to the virus. The "resistance" to HIV exposed but
      uninfected partners may be due to the absence of infection of target cells in the mucosa of
      the host, or to elimination of HIV or of infected cell during effective infection. Biological
      factors that govern individual resistance to HIV remain poorly understood. An immune response
      directed against cervicovaginal HIV antigens, including viral envelope glycoproteins has been
      described in a small number of HIV-negative women sexually exposed to the virus and resistant
      to infection. These observations demonstrate that there is a compartmentalization of the
      mucosal immune response of women, which can be induced against HIV antigens independently of
      systemic humoral immunity. In addition, a cytotoxic cervicovaginal immunity against HIV has
      been shown in some women, suggesting that viral antigens are presented to the immune system
      in a HLA-I, and therefore that HIV antigens were able to cross the mucosal barrier. A second
      hypothesis, which does not exclude the first, is that an immune response can be induced by
      repeated deposition of viral antigens on the cervicovaginal mucosa. It has been shown in HEPS
      women (Highly sexually exposed to HIV-1 persistently IgG seronegative purpose) the existence
      of IgA antibodies directed against gp41 can inhibit both the transcytosis of the virus
      through a monolayer epithelial cells and to neutralize the infection of CD4 T cells in vitro.

      Soluble factors also play an important role in mucosal transmission of HIV. Indeed,
      lymphokines RANTES, MIP-1a and MIP-1b, SDF-1 natural ligands of HIV co-receptors are found in
      varying concentrations in vaginal secretions. More recently, it has been shown that the
      CCL20/MIP3alpha, which is produced by epithelial cells genital HIV could interact with X4-and
      R5-tropic to inhibit infection.

      The most common techniques used to study the immunological and microbiological factors of
      female genital tract are cervicovaginal lavage (CVL) and swabbing the cervix. As part of a
      comprehensive approach to different aspects of mucosal immunity, it is necessary to use
      techniques for the acquisition of a large number of information while using small amounts of
      samples. Thus, techniques such as transcriptomic analysis on microarrays, which can tell us
      about changes in thousands of genes, and the use of techniques for multiplex quantification
      of soluble factors (cytokines and soluble factors of immunity innate mucosal) must be
      adapted, tested and validated before the start of a vaccine trial so that the samples needed
      for immunological assessment be exploited optimally.

      A first phase I trial (ANRS VAC14) evaluating the safety and immunogenicity in mucosal and
      systemic recombinant gp160 protein oligomeric administered nasally or vaginally with or
      without adjuvant (DC-Chol), was performed in women seronegative for HIV. The goal was to
      induce secretory IgA (SIgA) level specific genital mucosa. In this study, the storage
      conditions of the supernatants of cervicovaginal secretions and cells were not optimal for a
      study of the transcriptome. However, on a few samples we have shown the feasibility of
      transcriptomic analysis using Illumina technology. We were able on these samples to determine
      the profiles of mRNA expression and cytokine profiles. These preliminary results led us to
      propose for the new study, to preserve RNA, cell pellets treated with buffer RLT+ Qiagen
      before freezing at -80 °C. In addition, protease inhibitors are added directly into the
      washing liquid to preserve cervicovaginal immunoglobulins and cytokines degradation.

      We propose here a feasibility study of the immunological and transcriptomic analysis of
      cervicovaginal samples of women infected or not infected with HIV-1. Secondarily we assess
      tolerance samples taken by cytobrush and cervicovaginal washings, efficiency and
      reproducibility of the sample by cytobrush and cervicovaginal lavage for transcriptomic
      analysis, measurement of cytokines by Luminex technology, quantification of IgG and IgA. In
      blood we will determine the phenotype of B cells and Tfh cell frequency (T follicular helper)
      and quantification of serum immunoglobulins and will perform a transcriptomic analysis of
      blood cells. Finally we will make correlations with the observed responses at the genital
      mucosa.

      This pathophysiological exploratory study will be performed in 20 women infected with HIV-1
      and 20 healthy women recruited from two centers in France and will include a screening visit
      and two visits M0 and M1 during which mucous and blood samples will be performed.

      The results of the study will capitalize skills in biology mucosa, using powerful tools to
      assess mucosal immunological parameters. These standardized tools can be used both for the
      evaluation of mucosal immune response induced by prototype vaccines, and cohort studies to
      search for correlates of protection. These tools can also be used in the evaluation of the
      local tolerance to the application of molecules with microbicides.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Acceptability, tolerance, Efficiency
time frame: 2 months
description: Acceptability
Local tolerance of sampling (particularly for collection by cytobrush), bleeding (need for protection, abundance, frequency) leucorrhoea (frequency, amount, aspect), fever, pain, gynecological vaginal burns and general tolerance (fever, occurrence of pelvic infection).
Efficiency of collection by washing (Ig rate > 1μg/ml) and quality of cells collected by cytobrush and of cell pellet from washes for a transcriptomic analysis (the quantity and quality of RNA: RIN (RNA integrity number) > 5 and an amount of RNA 50> ng)
measure: Concentration of antibodies in cervicovaginal samples
time frame: Month 0 and month 1
description: Concentration of antibodies in cervicovaginal samples
measure: Concentration of cytokines in cervicovaginal samples
time frame: month 0 and month 1
description: Concentration of cytokines in cervicovaginal samples
measure: Expression genomics in cervicovaginal specimens and whole blood
time frame: month 0 and month 1
description: Expression genomics in cervicovaginal specimens and whole blood
measure: B phenotypes and the frequency of Tfh cells in whole blood
time frame: month 0 and month 1
description: B phenotypes and the frequency of Tfh cells in whole blood
arm group label: Healthy women volunteers
arm group type: Other
description: Healthy women volunteers with vaginal swabs by washing and cytobrush
arm group label: HIV-1 infected women
arm group type: Other
description: HIV-1 infected women with vaginal swabs by washing and cytobrush
intervention type: Procedure
intervention name: vaginal swabs by washing and cytobrush
description: vaginal swabs by washing and cytobrush
arm group label: HIV-1 infected women
arm group label: Healthy women volunteers
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fréderic LUCHT, PU PH
role: Principal Investigator
affiliation: Service des Maladies Infectieuses et Tropicales,CIC-EC, CHU Saint Etienne
last name: Odile LAUNAY, PU PH
role: Principal Investigator
affiliation: Centre d'investigation clinique Cochin Pasteur (CIC 1417), hôpital Cochin Paris
facility: 
facility: 
country: France
responsible party type: Sponsor