<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/NCT02262403</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-HIRP-01</org_study_id>
    <nct_id>NCT02262403</nct_id>
  </id_info>
  <brief_title>Hookworm Immune Regulation Project</brief_title>
  <acronym>HIRP-01</acronym>
  <official_title>Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université Libre de Bruxelles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brugmann University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to characterize the regulatory immune response induced by&#xD;
      hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution&#xD;
      after infection treatment and during potential naturally reinfection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be&#xD;
      recruited and treated according to Good Clinical Practice recommendations.&#xD;
&#xD;
      Allergy will be excluded by skin prick tests. Amount and phenotype of Treg will be explored&#xD;
      at several time points. Subsequent culture with environmental antigen will be performed on&#xD;
      cryopreserved cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount and phenotype of Treg</measure>
    <time_frame>0-12 weeks</time_frame>
    <description>Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).</description>
  </primary_outcome>
  <other_outcome>
    <measure>PBMC culture and cryopreservation</measure>
    <time_frame>after 12 weeks</time_frame>
    <description>Assessment of the orientation of the adaptative immune response to Dermatophagoides pteronyssinus.Subsequent Treg function testing and cell cultures (with environmental antigen) on cryopreserved PBMC (Peripheral Blood Mononuclear cells).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hookworm Infection</condition>
  <arm_group>
    <arm_group_label>Hookworm infected</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non infected (hookworms) healthy subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood and feces sampling</intervention_name>
    <description>Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.</description>
    <arm_group_label>Hookworm infected</arm_group_label>
    <arm_group_label>Non infected (hookworms) healthy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years old adults in good health status&#xD;
&#xD;
          -  To live in rural regions at risk of soil transmitted helminthes&#xD;
&#xD;
          -  Hookworm infection (infected group)&#xD;
&#xD;
          -  Uninfected by Hookworms (control group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Positive allergic history&#xD;
&#xD;
          -  Auto-immune and/or HIV disease&#xD;
&#xD;
          -  Antihelminthics drug in the last 6 months and other current parasitic infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginie Doyen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann - ULB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pham Ngoc Thach University of Medecine</name>
      <address>
        <city>Ho Chi Minh City</city>
        <state>Distict 10</state>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <reference>
    <citation>Flohr C, Tuyen LN, Quinnell RJ, Lewis S, Minh TT, Campbell J, Simmons C, Telford G, Brown A, Hien TT, Farrar J, Williams H, Pritchard DI, Britton J. Reduced helminth burden increases allergen skin sensitization but not clinical allergy: a randomized, double-blind, placebo-controlled trial in Vietnam. Clin Exp Allergy. 2010 Jan;40(1):131-42. doi: 10.1111/j.1365-2222.2009.03346.x. Epub 2009 Sep 15.</citation>
    <PMID>19758373</PMID>
  </reference>
  <reference>
    <citation>Flohr C, Tuyen LN, Lewis S, Quinnell R, Minh TT, Liem HT, Campbell J, Pritchard D, Hien TT, Farrar J, Williams H, Britton J. Poor sanitation and helminth infection protect against skin sensitization in Vietnamese children: A cross-sectional study. J Allergy Clin Immunol. 2006 Dec;118(6):1305-11. doi: 10.1016/j.jaci.2006.08.035. Epub 2006 Oct 13.</citation>
    <PMID>17157661</PMID>
  </reference>
  <reference>
    <citation>Finlay CM, Walsh KP, Mills KH. Induction of regulatory cells by helminth parasites: exploitation for the treatment of inflammatory diseases. Immunol Rev. 2014 May;259(1):206-30. doi: 10.1111/imr.12164.</citation>
    <PMID>24712468</PMID>
  </reference>
  <reference>
    <citation>Sakaguchi S, Vignali DA, Rudensky AY, Niec RE, Waldmann H. The plasticity and stability of regulatory T cells. Nat Rev Immunol. 2013 Jun;13(6):461-7. doi: 10.1038/nri3464. Epub 2013 May 17.</citation>
    <PMID>23681097</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Olivier Michel</investigator_full_name>
    <investigator_title>Head of clinic</investigator_title>
  </responsible_party>
  <keyword>Hookworm</keyword>
  <keyword>Helminths</keyword>
  <keyword>Treg</keyword>
  <keyword>Immune regulation</keyword>
  <keyword>Vietnam</keyword>
  <keyword>Allergic diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Hookworm Infections</mesh_term>
    <mesh_term>Ancylostomiasis</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/NCT02262403
org study id: CHUB-HIRP-01
nct id: NCT02262403
lead sponsor: 
collaborator: 
has dmc: No
The main objective of this study is to characterize the regulatory immune response induced by
      hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution
      after infection treatment and during potential naturally reinfection.
Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be
      recruited and treated according to Good Clinical Practice recommendations.

      Allergy will be excluded by skin prick tests. Amount and phenotype of Treg will be explored
      at several time points. Subsequent culture with environmental antigen will be performed on
      cryopreserved cells.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Amount and phenotype of Treg
time frame: 0-12 weeks
description: Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).
measure: PBMC culture and cryopreservation
time frame: after 12 weeks
description: Assessment of the orientation of the adaptative immune response to Dermatophagoides pteronyssinus.Subsequent Treg function testing and cell cultures (with environmental antigen) on cryopreserved PBMC (Peripheral Blood Mononuclear cells).
arm group label: Hookworm infected
arm group type: Experimental
description: The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed.
arm group label: Non infected (hookworms) healthy subjects
arm group type: Active Comparator
description: All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group.
intervention type: Other
intervention name: Blood and feces sampling
description: Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.
arm group label: Hookworm infected
arm group label: Non infected (hookworms) healthy subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Virginie Doyen, MD
role: Principal Investigator
affiliation: CHU Brugmann - ULB
facility: 
country: Vietnam
citation: Flohr C, Tuyen LN, Quinnell RJ, Lewis S, Minh TT, Campbell J, Simmons C, Telford G, Brown A, Hien TT, Farrar J, Williams H, Pritchard DI, Britton J. Reduced helminth burden increases allergen skin sensitization but not clinical allergy: a randomized, double-blind, placebo-controlled trial in Vietnam. Clin Exp Allergy. 2010 Jan;40(1):131-42. doi: 10.1111/j.1365-2222.2009.03346.x. Epub 2009 Sep 15.
PMID: 19758373
citation: Flohr C, Tuyen LN, Lewis S, Quinnell R, Minh TT, Liem HT, Campbell J, Pritchard D, Hien TT, Farrar J, Williams H, Britton J. Poor sanitation and helminth infection protect against skin sensitization in Vietnamese children: A cross-sectional study. J Allergy Clin Immunol. 2006 Dec;118(6):1305-11. doi: 10.1016/j.jaci.2006.08.035. Epub 2006 Oct 13.
PMID: 17157661
citation: Finlay CM, Walsh KP, Mills KH. Induction of regulatory cells by helminth parasites: exploitation for the treatment of inflammatory diseases. Immunol Rev. 2014 May;259(1):206-30. doi: 10.1111/imr.12164.
PMID: 24712468
citation: Sakaguchi S, Vignali DA, Rudensky AY, Niec RE, Waldmann H. The plasticity and stability of regulatory T cells. Nat Rev Immunol. 2013 Jun;13(6):461-7. doi: 10.1038/nri3464. Epub 2013 May 17.
PMID: 23681097
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Olivier Michel
investigator title: Head of clinic
mesh term: Infections
mesh term: Hookworm Infections
mesh term: Ancylostomiasis