xml: <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/NCT05965635</url>
    </required_header>
    <id_info>
      <org_study_id>NL81259.018.22</org_study_id>
      <nct_id>NCT05965635</nct_id>
    </id_info>
    <brief_title>The Uninfected Ixodes Scapularis Human Tick Challenge Model</brief_title>
    <acronym>TICK ME</acronym>
    <official_title>The Uninfected Ixodes Scapularis Human Tick Challenge Model</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        An innovative way to prevent multiple tick-borne diseases is an anti-tick vaccine, i.e.&#xD;
        targeting the vector to prevent transmission of pathogens from the tick to the host. The&#xD;
        rationale for an anti-tick vaccine stems from a phenomenon coined tick immunity. This study&#xD;
        aims to show proof of concept that humans indeed develop immunity to ticks. Therefore&#xD;
        subjects will be challenged three to four times with ticks reared in colony from a designated&#xD;
        laboratory and that are exhaustively tested negative for various known tick-borne pathogens.&#xD;
        Several tick feeding parameters will be evaluated to assess the development of tick immunity&#xD;
        in the subjects. To this end, a total amount of ten ticks per challenge will be placed under&#xD;
        a dressing placed on the forearm. The primary study endpoint is the tick feeding phenotype.&#xD;
        Secondary parameters are signs of an immune response in the host; itch, redness, or other&#xD;
        signs of a (local) immune response (blood and skin biopsies). All parameters, except for the&#xD;
        skin biopsies, will be collected/evaluated after each tick challenge.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be an, single centre, experimental study. The design of the study is similar to a&#xD;
        human challenge trial, with the important exception that the subjects in this study are not&#xD;
        experimentally infected with a pathogen, but are exposed to well-characterized&#xD;
        laboratory-reared uninfected nymphal Ixodes scapularis ticks.&#xD;
  &#xD;
        Seven healthy human volunteers of &gt;18 years old who have no history of known tick-bites or&#xD;
        tick-borne diseases will be recruited. Subjects will undergo three to four tick challenges,&#xD;
        consisting of five to six days per challenge with two weeks between the consecutive&#xD;
        challenges. The total duration of participation is approximately five months for each&#xD;
        subject. By making use of ticks from a laboratory-reared tick colony that have been, and are&#xD;
        being, used in xenodiagnosis and tick challenge models in the USA and that are well tolerated&#xD;
        minimizing the risks of the tick challenges. Regardless, the tick challenge can cause some&#xD;
        discomfort because of possible local reactions and because the dressing must be kept dry for&#xD;
        five to six days. The risk of infection with a tick-borne pathogen is negligible due to the&#xD;
        fact that these ticks are exhaustively tested for various known tick-borne pathogens.&#xD;
        Finally, risks are considerated of development of a red meat allergy or other allergic&#xD;
        reactions negligible because no clear associations are known of I. scapularis ticks and red&#xD;
        meat allergy. No serious adverse events (such as human infections or red meat allergy) have&#xD;
        resulted from more than &gt;100 challenges in the United States using this tick colony. There&#xD;
        are no direct benefits of participation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>
      <intervention_model_description>Single centre, experimental study</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tick weight</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>Tick weight in mg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tick feeding molting success</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>Molting success rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tick survival</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>tick survival rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tick attachment</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>tick attachment rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Signs of an immune response in the host: Itch</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>Itch</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Signs of an immune response in the host: redness</measure>
      <time_frame>Up to 1 week</time_frame>
      <description>Redness</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Signs of an immune response in the host: other</measure>
      <time_frame>3 weeks</time_frame>
      <description>Other signs of a local immune response (in blood)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Signs of an immune response in the host: biopsies</measure>
      <time_frame>9 weeks</time_frame>
      <description>Other signs of a local immune response (in skin biopsies)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Tick Bites</condition>
    <condition>Tick Immunity</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ixodus scapularis nymphs</intervention_name>
      <description>Tick challenge</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 18 years and older;&#xD;
  &#xD;
            -  Negative Borrelia VlsE1/pepC10 ELISA.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known history of tick bites;&#xD;
  &#xD;
            -  Positive Borrelia serology (VlsE1/PepC10 ELISA);&#xD;
  &#xD;
            -  Known history or current suspicion on any tick-borne disease;&#xD;
  &#xD;
            -  Chronic skin condition affecting the arm skin;&#xD;
  &#xD;
            -  Inability to maintain the dressing for any reason;&#xD;
  &#xD;
            -  Known immunodeficiency or autoimmune disease;&#xD;
  &#xD;
            -  Use of systemic immunomodulating drugs or chemotherapy, current or in the past;&#xD;
  &#xD;
            -  Chronic use of antibiotics;&#xD;
  &#xD;
            -  Unable to give informed consent or do not have a thorough command of the Dutch&#xD;
               language;&#xD;
  &#xD;
            -  Refusal to participate in specimen collection and storage for future study related&#xD;
               use;&#xD;
  &#xD;
            -  Pregnant or breastfeeding women;&#xD;
  &#xD;
            -  Not willing to use adequate contraception during the study period;&#xD;
  &#xD;
            -  Red meat allergy (both medically confirmed and self-reported);&#xD;
  &#xD;
            -  Use of investigational therapy and devices during the time of the study;&#xD;
  &#xD;
            -  Any other condition that, in the opinion of the investigator, would make the patient&#xD;
               unsuitable for enrolment or could interfere with the patient participating in and&#xD;
               completing the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hannelore. JL Beaart, PhD</last_name>
      <phone>+31205667906</phone>
      <email>tickme@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stefanie A Gauw, Coordinator</last_name>
      <phone>+31205667906</phone>
      <email>tickme@amsterdamumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>AUMC location AMC</name>
        <address>
          <city>Amsterdam-Zuidoost</city>
          <state>Noord-Holland</state>
          <zip>1105 AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>H. Beaart, Msc</last_name>
        <phone>0031207327170</phone>
        <email>TICKME@amsterdamumc.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>prof. J.W.R. Hovius, MD, PhD</investigator_full_name>
      <investigator_title>PI</investigator_title>
    </responsible_party>
    <keyword>Tick bites</keyword>
    <keyword>Ixodus scapularis</keyword>
    <keyword>Tick Challenge model</keyword>
    <keyword>Tick borne diseases</keyword>
    <keyword>Tick immunity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tick Bites</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965635
  org study id: NL81259.018.22
  nct id: NCT05965635
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  An innovative way to prevent multiple tick-borne diseases is an anti-tick vaccine, i.e.
        targeting the vector to prevent transmission of pathogens from the tick to the host. The
        rationale for an anti-tick vaccine stems from a phenomenon coined tick immunity. This study
        aims to show proof of concept that humans indeed develop immunity to ticks. Therefore
        subjects will be challenged three to four times with ticks reared in colony from a designated
        laboratory and that are exhaustively tested negative for various known tick-borne pathogens.
        Several tick feeding parameters will be evaluated to assess the development of tick immunity
        in the subjects. To this end, a total amount of ten ticks per challenge will be placed under
        a dressing placed on the forearm. The primary study endpoint is the tick feeding phenotype.
        Secondary parameters are signs of an immune response in the host; itch, redness, or other
        signs of a (local) immune response (blood and skin biopsies). All parameters, except for the
        skin biopsies, will be collected/evaluated after each tick challenge.
  This will be an, single centre, experimental study. The design of the study is similar to a
        human challenge trial, with the important exception that the subjects in this study are not
        experimentally infected with a pathogen, but are exposed to well-characterized
        laboratory-reared uninfected nymphal Ixodes scapularis ticks.
  
        Seven healthy human volunteers of >18 years old who have no history of known tick-bites or
        tick-borne diseases will be recruited. Subjects will undergo three to four tick challenges,
        consisting of five to six days per challenge with two weeks between the consecutive
        challenges. The total duration of participation is approximately five months for each
        subject. By making use of ticks from a laboratory-reared tick colony that have been, and are
        being, used in xenodiagnosis and tick challenge models in the USA and that are well tolerated
        minimizing the risks of the tick challenges. Regardless, the tick challenge can cause some
        discomfort because of possible local reactions and because the dressing must be kept dry for
        five to six days. The risk of infection with a tick-borne pathogen is negligible due to the
        fact that these ticks are exhaustively tested for various known tick-borne pathogens.
        Finally, risks are considerated of development of a red meat allergy or other allergic
        reactions negligible because no clear associations are known of I. scapularis ticks and red
        meat allergy. No serious adverse events (such as human infections or red meat allergy) have
        resulted from more than >100 challenges in the United States using this tick colony. There
        are no direct benefits of participation.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single centre, experimental study
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Tick weight
  time frame: Up to 1 week
  description: Tick weight in mg
  measure: Tick feeding molting success
  time frame: Up to 1 week
  description: Molting success rate
  measure: Tick survival
  time frame: Up to 1 week
  description: tick survival rate
  measure: Tick attachment
  time frame: Up to 1 week
  description: tick attachment rate
  measure: Signs of an immune response in the host: Itch
  time frame: Up to 1 week
  description: Itch
  measure: Signs of an immune response in the host: redness
  time frame: Up to 1 week
  description: Redness
  measure: Signs of an immune response in the host: other
  time frame: 3 weeks
  description: Other signs of a local immune response (in blood)
  measure: Signs of an immune response in the host: biopsies
  time frame: 9 weeks
  description: Other signs of a local immune response (in skin biopsies)
  arm group label: Experimental
  arm group type: Experimental
  intervention type: Other
  intervention name: Ixodus scapularis nymphs
  description: Tick challenge
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hannelore. JL Beaart, PhD
  phone: +31205667906
  email: tickme@amsterdamumc.nl
  last name: Stefanie A Gauw, Coordinator
  phone: +31205667906
  email: tickme@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: prof. J.W.R. Hovius, MD, PhD
  investigator title: PI
  mesh term: Tick Bites
  sharing ipd: No