<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/NCT02996890</url>
  </required_header>
  <id_info>
    <org_study_id>V186-001</org_study_id>
    <secondary_id>2016-004212-34</secondary_id>
    <secondary_id>MV-ZIKA-101</secondary_id>
    <nct_id>NCT02996890</nct_id>
  </id_info>
  <brief_title>Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)</brief_title>
  <official_title>Double Blinded, Randomized, Placebo Controlled, Dose Finding Trial to Evaluate the Optimal Dose of MV-ZIKA, a New Vaccine Against Zika Virus, in Regard to Immunogenicity, Safety, and Tolerability in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Themis Bioscience GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Themis Bioscience GmbH</source>
  <oversight_info>
    <has_dmc>No</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>
      Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in&#xD;
      48 healthy volunteer subjects.&#xD;
&#xD;
      After completion of screening procedures, the subjects are randomized to one of four&#xD;
      treatment groups (different dosage strengths and placebo) All subjects will receive study&#xD;
      treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with&#xD;
      two vaccinations will receive a second treatment at day 28.&#xD;
&#xD;
      Subjects will return on day 56 for the final visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">April 17, 2018</completion_date>
  <primary_completion_date type="Actual">January 4, 2018</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunogenicity: Functional anti-Zika antibodies as measured by PRNT</measure>
    <time_frame>56 days</time_frame>
    <description>Functional anti-Zika antibodies as measured by PRNT.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Zika Virus</condition>
  <arm_group>
    <arm_group_label>High dose - single shot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MV-ZIKA, high dose, one vaccination, day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MV-ZIKA, low dose, two vaccinations, day 0 and day 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MV-ZIKA, high dose, two vaccinations, day 0 and day 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Physiological saline, two treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MV-ZIKA</intervention_name>
    <description>MV-Zika vaccine</description>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_label>High dose - single shot</arm_group_label>
    <arm_group_label>Low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>physiological saline</description>
    <arm_group_label>High dose - single shot</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers aged 18 to 55&#xD;
&#xD;
          -  subjects of child bearing potential must perform reliable method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  immune deficiency, history of HIV, HBV, HCV&#xD;
&#xD;
          -  drug addiction&#xD;
&#xD;
          -  vaccination within 4 weeks prior to study or planned vaccination during study&#xD;
&#xD;
          -  prior receipt of any Zika vaccine&#xD;
&#xD;
          -  recent infection 1 week prior to screening&#xD;
&#xD;
          -  relevant medical history interfering with aim of study&#xD;
&#xD;
          -  neoplastic disease, hematological malignancy&#xD;
&#xD;
          -  history of autoimmune disease&#xD;
&#xD;
          -  psychological condition that affects ability to participate in the study&#xD;
&#xD;
          -  history of severe adverse reactions to vaccine administration&#xD;
&#xD;
          -  history of anaphylaxis&#xD;
&#xD;
          -  allergic reactions, abnormal lab values, or concomitant medication per decision of the&#xD;
             investigator&#xD;
&#xD;
          -  use of immunosuppressive drugs within 30 days before screening or planned use during&#xD;
             study&#xD;
&#xD;
          -  receipt of blood products within 120 days before screening or planned use during study&#xD;
&#xD;
          -  pregnancy, unreliable contraception method&#xD;
&#xD;
          -  decision of the investigator&#xD;
&#xD;
          -  regular blood plasma donor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Vienna, Department of Clinical Pharmacology</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <!-- 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/NCT02996890
org study id: V186-001
secondary id: 2016-004212-34
secondary id: MV-ZIKA-101
nct id: NCT02996890
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in
      48 healthy volunteer subjects.

      After completion of screening procedures, the subjects are randomized to one of four
      treatment groups (different dosage strengths and placebo) All subjects will receive study
      treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with
      two vaccinations will receive a second treatment at day 28.

      Subjects will return on day 56 for the final visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
time frame: 56 days
description: Functional anti-Zika antibodies as measured by PRNT.
arm group label: High dose - single shot
arm group type: Experimental
description: MV-ZIKA, high dose, one vaccination, day 0
arm group label: Low dose
arm group type: Experimental
description: MV-ZIKA, low dose, two vaccinations, day 0 and day 28
arm group label: High dose
arm group type: Experimental
description: MV-ZIKA, high dose, two vaccinations, day 0 and day 28
arm group label: Placebo
arm group type: Placebo Comparator
description: Physiological saline, two treatments
intervention type: Biological
intervention name: MV-ZIKA
description: MV-Zika vaccine
arm group label: High dose
arm group label: High dose - single shot
arm group label: Low dose
intervention type: Other
intervention name: Placebo
description: physiological saline
arm group label: High dose - single shot
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Zika Virus Infection
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php