<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/NCT01707602</url>
  </required_header>
  <id_info>
    <org_study_id>P120201</org_study_id>
    <secondary_id>2012-001967-55</secondary_id>
    <nct_id>NCT01707602</nct_id>
  </id_info>
  <brief_title>Routes of Immunization and Flu Immune Responses</brief_title>
  <acronym>FLUWAY</acronym>
  <official_title>Impact of Immunization Routes on the Immune Response to Influenza Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project aims to evaluate the impact of skin routes of immunization (transcutaneous and&#xD;
      intradermal vs intramuscular) on cellular and humoral responses to seasonal influenza&#xD;
      vaccination in adults (18-45 years old).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      New approaches addressing intradermal (ID) and transcutaneous (TC) routes of immunization&#xD;
      have been developed over the past few years and have brought novel insight in quality and&#xD;
      efficacy of the immune response. Indeed, compared to the muscular tissue widely used for&#xD;
      vaccination, the skin is particularly rich in antigen presenting cells. Our recent works show&#xD;
      that penetration of vaccine compounds into the hair follicular ducts surrounded by Langerhans&#xD;
      cells induces potent cellular immunity in contrast to the intra-muscular immunization. Our&#xD;
      results also suggest that differential targeting of epidermal Langerhans cells (by TC route)&#xD;
      or dermal dendritic cells (by ID route) could modulate the intensity and quality of the&#xD;
      immune response to vaccine.&#xD;
&#xD;
      The aim of this study is to evaluate the immune response to a seasonal influenza vaccine when&#xD;
      administrated byTC (hair follicular targeting needle-free method), ID (micro-needle&#xD;
      injection) and IM (conventional intramuscular injection) routes of immunization. Along with&#xD;
      our previous pre-clinical and clinical studies, here we hypothesize that differential&#xD;
      targeting of epidermis or dermis antigen-presenting cells will have a differential impact on&#xD;
      the cellular and humoral immune responses to Influenza vaccine.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      We will conduct a phase I/II clinical trials on 60 healthy volunteers to compare TC and ID&#xD;
      routes of immunization to the conventional intramuscular (IM) vaccination. The impact of&#xD;
      these routes on cellular and humoral immune responses to seasonal influenza vaccine will be&#xD;
      assessed at baseline, day 21 (effector phase) and month 5 (memory phase) after vaccination.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      Using the seasonal Influenza vaccine as an example of conventional vaccine, this study will&#xD;
      evaluate and compare the efficacy ofTC, ID and IMroutes of immunization to induce cellular&#xD;
      responses at day 21 and memory responses at month 5 phases. The generation and maintenance of&#xD;
      Flu specific and neutralizing antibodies will be measured by Haemagglutination Inhibition and&#xD;
      microneutralization assays.Moreover, safety and tolerance to each vaccination methods will be&#xD;
      evaluated as well as inflammation and innate immune response induced at day 1 after&#xD;
      vaccination.&#xD;
&#xD;
      Addressing innovative skin routes of immunization, this study represents an essential step to&#xD;
      move forward in the development of new vaccination strategies. These results will have an&#xD;
      important impact on the amelioration of vaccine efficacy and less invasive method of&#xD;
      immunization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD8 T cell responses</measure>
    <time_frame>21 days</time_frame>
    <description>CD8 T cell responses against the specific vaccine strain will be measured at baseline and day 21 after vaccination by flow cytometry. Secretion of cytokines measured by intracellular staining will be compared between TC, ID and IM routes of vaccination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>5 months</time_frame>
    <description>Safety will be assessed at each visit by recording clinical local and systemic tolerance including reporting of adverse events. Frequency and severity of local and systemic adverse events following vaccination will be compared between TC, ID and IM vaccination groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemagglutination Inhibition</measure>
    <time_frame>5 months</time_frame>
    <description>Haemagglutination Inhibition and microneutralization assays will be performed at day0, day 21 and month 5 after vaccination to define the humoral response against a vaccine-homologous virus that meets or exceeds the EMEA (CHMP) guidance targets for influenza vaccine seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean fold rise (GMFR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 T cell responses</measure>
    <time_frame>21 days</time_frame>
    <description>CD4 T cell responses against the specific vaccine strain will be measured at baseline and day 21 by intracellular staining and flow cytometry. Effector CD4 T cell responses will be compared between TC, ID and IM vaccination groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory CD8 and CD4 T cell responses</measure>
    <time_frame>5 months</time_frame>
    <description>Memory CD8 and CD4 T cell responses against the specific vaccine strain will be assessed by flow cytometry 5 month after vaccination by TC, ID and IM routes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>1 day</time_frame>
    <description>Inflammation and systemic innate immune response will be assessed on day 1 after vaccination (compared with the basal inflammatory status) by studying the transcriptional profile of blood cells (microarrays) and inflammatory cytokines dosage in the serum.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Type Vaccine Name: INTANZA® 15 T Description : transcutaneous vaccination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Type: Vaccine Name: INTANZA® 15ug Description : intradermal vaccination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Type : Vaccine Name: Vaxigrip® Description :Intramuscular vaccination</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>INTANZA® 15</intervention_name>
    <description>intradermal vaccination</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vaxigrip®</intervention_name>
    <description>Intramuscular vaccination</description>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>INTANZA® 15 T</intervention_name>
    <description>transcutaneous vaccination</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers, age between 18 and 45 years,&#xD;
&#xD;
          -  BMI between 21 - 26,&#xD;
&#xD;
          -  Phototype I to IV,&#xD;
&#xD;
          -  Subjects able to receive vaccine administration by any of the three administration&#xD;
             routes,&#xD;
&#xD;
          -  Signature of the written informed consent,&#xD;
&#xD;
          -  Affiliated to a health social security system,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy or positive urine pregnancy test for women of child-bearing age,&#xD;
&#xD;
          -  Known infection with HIV or/and HCV or/and HBV (AgHBs+),&#xD;
&#xD;
          -  Known or suspected immune dysfunction that is caused by a medical condition, or any&#xD;
             other Cause,&#xD;
&#xD;
          -  Use, within the past 3 months, of any topical and systemic treatment that would&#xD;
             interfere with assessment and/or investigational treatment (anti-inflammatory drugs,&#xD;
             immunosuppressors or any immune modulator agent),&#xD;
&#xD;
          -  Use of any topical treatment on the injection site within the last four weeks,&#xD;
&#xD;
          -  Excessive terminal hair growth on the two investigational skin areas used for the&#xD;
             transcutaneous mode of vaccination,&#xD;
&#xD;
          -  Phototype V-VI,&#xD;
&#xD;
          -  Any allergy or hypersensibility to one of the components of the Investigational&#xD;
             Product,&#xD;
&#xD;
          -  Medical history of allergy or hypersensitization to any ingredient of colorant used in&#xD;
             the transcutaneous mode of administration,&#xD;
&#xD;
          -  Administration of a live vaccine(≤ 28 days) or inactivated (≤ 14 days) or planned&#xD;
             vaccination within 3months of inclusion (D0),&#xD;
&#xD;
          -  Medical history of skin cancer,&#xD;
&#xD;
          -  Any acute skin affection which may interfere with the trial assessment on the&#xD;
             injection site,&#xD;
&#xD;
          -  Any acute or chronic infectious which may interfere with the trial assessment four&#xD;
             weeks prior to enrolment,&#xD;
&#xD;
          -  Prevision of UV sessions or sun exposure 6 weeks prior to the study or during the&#xD;
             study period,&#xD;
&#xD;
          -  Febrile illness(at least 37.5°Cmeasuredorally), any acute infectious event within one&#xD;
             week prior to enrolment,&#xD;
&#xD;
          -  Flu confirmed by the presence of fever≥38.5°Cassociated with respiratory symptoms&#xD;
&#xD;
          -  History of GuillainBarre syndrome or brachial neuritis following a previous&#xD;
             vaccination.&#xD;
&#xD;
          -  Participation in an other biomedical research during the study period or period of&#xD;
             exclusion when inclusion&#xD;
&#xD;
          -  Subject being in the exclusion period of a previous clinical trial,&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Odile LAUNAY, M.D. Ph. D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GH Cochin - Broca - Hôtel-Dieu CIC BT505</name>
      <address>
        <city>PARIS Cedex 14</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Combadiere B, Siberil S, Duffy D. Keeping the memory of influenza viruses. Pathol Biol (Paris). 2010 Apr;58(2):e79-86. doi: 10.1016/j.patbio.2010.01.010. Epub 2010 Mar 19.</citation>
    <PMID>20303671</PMID>
  </reference>
  <reference>
    <citation>McMichael AJ, Ting A, Zweerink HJ, Askonas BA. HLA restriction of cell-mediated lysis of influenza virus-infected human cells. Nature. 1977 Dec 8;270(5637):524-6. doi: 10.1038/270524a0. No abstract available.</citation>
    <PMID>593371</PMID>
  </reference>
  <reference>
    <citation>Combadiere B, Vogt A, Mahe B, Costagliola D, Hadam S, Bonduelle O, Sterry W, Staszewski S, Schaefer H, van der Werf S, Katlama C, Autran B, Blume-Peytavi U. Preferential amplification of CD8 effector-T cells after transcutaneous application of an inactivated influenza vaccine: a randomized phase I trial. PLoS One. 2010 May 26;5(5):e10818. doi: 10.1371/journal.pone.0010818.</citation>
    <PMID>20520820</PMID>
  </reference>
  <reference>
    <citation>Combadiere B, Liard C. Transcutaneous and intradermal vaccination. Hum Vaccin. 2011 Aug;7(8):811-27. doi: 10.4161/hv.7.8.16274. Epub 2011 Aug 1.</citation>
    <PMID>21817854</PMID>
  </reference>
  <reference>
    <citation>Lambert PH, Laurent PE. Intradermal vaccine delivery: will new delivery systems transform vaccine administration? Vaccine. 2008 Jun 19;26(26):3197-208. doi: 10.1016/j.vaccine.2008.03.095. Epub 2008 Apr 22.</citation>
    <PMID>18486285</PMID>
  </reference>
  <reference>
    <citation>Vogt A, Combadiere B, Hadam S, Stieler KM, Lademann J, Schaefer H, Autran B, Sterry W, Blume-Peytavi U. 40 nm, but not 750 or 1,500 nm, nanoparticles enter epidermal CD1a+ cells after transcutaneous application on human skin. J Invest Dermatol. 2006 Jun;126(6):1316-22. doi: 10.1038/sj.jid.5700226.</citation>
    <PMID>16614727</PMID>
  </reference>
  <reference>
    <citation>Vogt A, Mahe B, Costagliola D, Bonduelle O, Hadam S, Schaefer G, Schaefer H, Katlama C, Sterry W, Autran B, Blume-Peytavi U, Combadiere B. Transcutaneous anti-influenza vaccination promotes both CD4 and CD8 T cell immune responses in humans. J Immunol. 2008 Feb 1;180(3):1482-9. doi: 10.4049/jimmunol.180.3.1482.</citation>
    <PMID>18209043</PMID>
  </reference>
  <reference>
    <citation>Mahe B, Vogt A, Liard C, Duffy D, Abadie V, Bonduelle O, Boissonnas A, Sterry W, Verrier B, Blume-Peytavi U, Combadiere B. Nanoparticle-based targeting of vaccine compounds to skin antigen-presenting cells by hair follicles and their transport in mice. J Invest Dermatol. 2009 May;129(5):1156-64. doi: 10.1038/jid.2008.356. Epub 2008 Dec 4.</citation>
    <PMID>19052565</PMID>
  </reference>
  <reference>
    <citation>Liard C, Munier S, Arias M, Joulin-Giet A, Bonduelle O, Duffy D, Shattock RJ, Verrier B, Combadiere B. Targeting of HIV-p24 particle-based vaccine into differential skin layers induces distinct arms of the immune responses. Vaccine. 2011 Aug 26;29(37):6379-91. doi: 10.1016/j.vaccine.2011.04.080. Epub 2011 May 7.</citation>
    <PMID>21554912</PMID>
  </reference>
  <reference>
    <citation>Liard C, Munier S, Joulin-Giet A, Bonduelle O, Hadam S, Duffy D, Vogt A, Verrier B, Combadiere B. Intradermal immunization triggers epidermal Langerhans cell mobilization required for CD8 T-cell immune responses. J Invest Dermatol. 2012 Mar;132(3 Pt 1):615-25. doi: 10.1038/jid.2011.346. Epub 2011 Dec 15.</citation>
    <PMID>22170490</PMID>
  </reference>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>August 2, 2013</last_update_submitted>
  <last_update_submitted_qc>August 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intradermal</keyword>
  <keyword>transcutaneous</keyword>
  <keyword>influenza</keyword>
  <keyword>routes of vaccination</keyword>
  <keyword>T cell responses</keyword>
  <keyword>humoral responses</keyword>
  <keyword>skin</keyword>
  <keyword>clinical trial</keyword>
  <keyword>Novel application of influenza vaccine</keyword>
  <keyword>Transcutaneous vaccination(hair follicular targeting)</keyword>
  <keyword>Intradermal vaccination(micro-needle)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <!-- 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/NCT01707602
org study id: P120201
secondary id: 2012-001967-55
nct id: NCT01707602
lead sponsor: 
collaborator: 
has dmc: No
The project aims to evaluate the impact of skin routes of immunization (transcutaneous and
      intradermal vs intramuscular) on cellular and humoral responses to seasonal influenza
      vaccination in adults (18-45 years old).
New approaches addressing intradermal (ID) and transcutaneous (TC) routes of immunization
      have been developed over the past few years and have brought novel insight in quality and
      efficacy of the immune response. Indeed, compared to the muscular tissue widely used for
      vaccination, the skin is particularly rich in antigen presenting cells. Our recent works show
      that penetration of vaccine compounds into the hair follicular ducts surrounded by Langerhans
      cells induces potent cellular immunity in contrast to the intra-muscular immunization. Our
      results also suggest that differential targeting of epidermal Langerhans cells (by TC route)
      or dermal dendritic cells (by ID route) could modulate the intensity and quality of the
      immune response to vaccine.

      The aim of this study is to evaluate the immune response to a seasonal influenza vaccine when
      administrated byTC (hair follicular targeting needle-free method), ID (micro-needle
      injection) and IM (conventional intramuscular injection) routes of immunization. Along with
      our previous pre-clinical and clinical studies, here we hypothesize that differential
      targeting of epidermis or dermis antigen-presenting cells will have a differential impact on
      the cellular and humoral immune responses to Influenza vaccine.

      Objectives:

      We will conduct a phase I/II clinical trials on 60 healthy volunteers to compare TC and ID
      routes of immunization to the conventional intramuscular (IM) vaccination. The impact of
      these routes on cellular and humoral immune responses to seasonal influenza vaccine will be
      assessed at baseline, day 21 (effector phase) and month 5 (memory phase) after vaccination.

      Outcomes:

      Using the seasonal Influenza vaccine as an example of conventional vaccine, this study will
      evaluate and compare the efficacy ofTC, ID and IMroutes of immunization to induce cellular
      responses at day 21 and memory responses at month 5 phases. The generation and maintenance of
      Flu specific and neutralizing antibodies will be measured by Haemagglutination Inhibition and
      microneutralization assays.Moreover, safety and tolerance to each vaccination methods will be
      evaluated as well as inflammation and innate immune response induced at day 1 after
      vaccination.

      Addressing innovative skin routes of immunization, this study represents an essential step to
      move forward in the development of new vaccination strategies. These results will have an
      important impact on the amelioration of vaccine efficacy and less invasive method of
      immunization.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: CD8 T cell responses
time frame: 21 days
description: CD8 T cell responses against the specific vaccine strain will be measured at baseline and day 21 after vaccination by flow cytometry. Secretion of cytokines measured by intracellular staining will be compared between TC, ID and IM routes of vaccination.
measure: Safety
time frame: 5 months
description: Safety will be assessed at each visit by recording clinical local and systemic tolerance including reporting of adverse events. Frequency and severity of local and systemic adverse events following vaccination will be compared between TC, ID and IM vaccination groups.
measure: Haemagglutination Inhibition
time frame: 5 months
description: Haemagglutination Inhibition and microneutralization assays will be performed at day0, day 21 and month 5 after vaccination to define the humoral response against a vaccine-homologous virus that meets or exceeds the EMEA (CHMP) guidance targets for influenza vaccine seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean fold rise (GMFR).
measure: CD4 T cell responses
time frame: 21 days
description: CD4 T cell responses against the specific vaccine strain will be measured at baseline and day 21 by intracellular staining and flow cytometry. Effector CD4 T cell responses will be compared between TC, ID and IM vaccination groups.
measure: Memory CD8 and CD4 T cell responses
time frame: 5 months
description: Memory CD8 and CD4 T cell responses against the specific vaccine strain will be assessed by flow cytometry 5 month after vaccination by TC, ID and IM routes.
measure: Inflammation
time frame: 1 day
description: Inflammation and systemic innate immune response will be assessed on day 1 after vaccination (compared with the basal inflammatory status) by studying the transcriptional profile of blood cells (microarrays) and inflammatory cytokines dosage in the serum.
arm group label: Arm A
arm group type: Experimental
description: Type Vaccine Name: INTANZA® 15 T Description : transcutaneous vaccination
arm group label: Arm B
arm group type: Active Comparator
description: Type: Vaccine Name: INTANZA® 15ug Description : intradermal vaccination
arm group label: Arm C
arm group type: Active Comparator
description: Type : Vaccine Name: Vaxigrip® Description :Intramuscular vaccination
intervention type: Biological
intervention name: INTANZA® 15
description: intradermal vaccination
arm group label: Arm B
intervention type: Biological
intervention name: Vaxigrip®
description: Intramuscular vaccination
arm group label: Arm C
intervention type: Biological
intervention name: INTANZA® 15 T
description: transcutaneous vaccination
arm group label: Arm A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Odile LAUNAY, M.D. Ph. D
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: Combadiere B, Siberil S, Duffy D. Keeping the memory of influenza viruses. Pathol Biol (Paris). 2010 Apr;58(2):e79-86. doi: 10.1016/j.patbio.2010.01.010. Epub 2010 Mar 19.
PMID: 20303671
citation: McMichael AJ, Ting A, Zweerink HJ, Askonas BA. HLA restriction of cell-mediated lysis of influenza virus-infected human cells. Nature. 1977 Dec 8;270(5637):524-6. doi: 10.1038/270524a0. No abstract available.
PMID: 593371
citation: Combadiere B, Vogt A, Mahe B, Costagliola D, Hadam S, Bonduelle O, Sterry W, Staszewski S, Schaefer H, van der Werf S, Katlama C, Autran B, Blume-Peytavi U. Preferential amplification of CD8 effector-T cells after transcutaneous application of an inactivated influenza vaccine: a randomized phase I trial. PLoS One. 2010 May 26;5(5):e10818. doi: 10.1371/journal.pone.0010818.
PMID: 20520820
citation: Combadiere B, Liard C. Transcutaneous and intradermal vaccination. Hum Vaccin. 2011 Aug;7(8):811-27. doi: 10.4161/hv.7.8.16274. Epub 2011 Aug 1.
PMID: 21817854
citation: Lambert PH, Laurent PE. Intradermal vaccine delivery: will new delivery systems transform vaccine administration? Vaccine. 2008 Jun 19;26(26):3197-208. doi: 10.1016/j.vaccine.2008.03.095. Epub 2008 Apr 22.
PMID: 18486285
citation: Vogt A, Combadiere B, Hadam S, Stieler KM, Lademann J, Schaefer H, Autran B, Sterry W, Blume-Peytavi U. 40 nm, but not 750 or 1,500 nm, nanoparticles enter epidermal CD1a+ cells after transcutaneous application on human skin. J Invest Dermatol. 2006 Jun;126(6):1316-22. doi: 10.1038/sj.jid.5700226.
PMID: 16614727
citation: Vogt A, Mahe B, Costagliola D, Bonduelle O, Hadam S, Schaefer G, Schaefer H, Katlama C, Sterry W, Autran B, Blume-Peytavi U, Combadiere B. Transcutaneous anti-influenza vaccination promotes both CD4 and CD8 T cell immune responses in humans. J Immunol. 2008 Feb 1;180(3):1482-9. doi: 10.4049/jimmunol.180.3.1482.
PMID: 18209043
citation: Mahe B, Vogt A, Liard C, Duffy D, Abadie V, Bonduelle O, Boissonnas A, Sterry W, Verrier B, Blume-Peytavi U, Combadiere B. Nanoparticle-based targeting of vaccine compounds to skin antigen-presenting cells by hair follicles and their transport in mice. J Invest Dermatol. 2009 May;129(5):1156-64. doi: 10.1038/jid.2008.356. Epub 2008 Dec 4.
PMID: 19052565
citation: Liard C, Munier S, Arias M, Joulin-Giet A, Bonduelle O, Duffy D, Shattock RJ, Verrier B, Combadiere B. Targeting of HIV-p24 particle-based vaccine into differential skin layers induces distinct arms of the immune responses. Vaccine. 2011 Aug 26;29(37):6379-91. doi: 10.1016/j.vaccine.2011.04.080. Epub 2011 May 7.
PMID: 21554912
citation: Liard C, Munier S, Joulin-Giet A, Bonduelle O, Hadam S, Duffy D, Vogt A, Verrier B, Combadiere B. Intradermal immunization triggers epidermal Langerhans cell mobilization required for CD8 T-cell immune responses. J Invest Dermatol. 2012 Mar;132(3 Pt 1):615-25. doi: 10.1038/jid.2011.346. Epub 2011 Dec 15.
PMID: 22170490
responsible party type: Sponsor
mesh term: Influenza, Human