<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/NCT03807843</url>
  </required_header>
  <id_info>
    <org_study_id>V184-006</org_study_id>
    <secondary_id>MV-CHIK-206</secondary_id>
    <nct_id>NCT03807843</nct_id>
  </id_info>
  <brief_title>Chikungunya Vaccine (V184) Study in Previously Exposed Adults (V184-006)</brief_title>
  <official_title>Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Themis Bioscience GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Walter Reed Army Institute of Research (WRAIR)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Themis Bioscience GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in&#xD;
      participants with history of chikungunya infection. Initially 21 to 50 year old participants&#xD;
      will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be&#xD;
      enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomized double-blind interventional clinical study. This study proposes to&#xD;
      evaluate the safety and immunogenicity of the investigational V184 live recombinant&#xD;
      measles-vectored chikungunya vaccine delivered in 2 vaccinations, 28 days apart compared with&#xD;
      saline placebo. After providing informed consent, individuals will be screened for&#xD;
      eligibility including verification of previous exposure to chikungunya virus. They will then&#xD;
      be randomized in a double-blind fashion to receive either V184 or saline placebo in a 1:1&#xD;
      ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2019</start_date>
  <completion_date type="Actual">May 13, 2021</completion_date>
  <primary_completion_date type="Actual">May 13, 2021</primary_completion_date>
  <phase>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>
    <intervention_model_description>Placebo-controlled, randomized, double-blinded, interventional, safety study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Study medication is available as liquid frozen vaccine product or saline for injection (placebo). The actual study injections will be forwarded to the investigator (injector) in a blinded fashion (injection ready syringes containing either vaccine or placebo).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Solicited Adverse Events (AEs)</measure>
    <time_frame>Up to 7 days after vaccination (up to Day 35)</time_frame>
    <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Solicited AEs&quot; included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. The number of participants with solicited AEs following Vaccination 1 (Day 0) or Vaccination 2 (Day 28) were reported for each group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited AEs</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Unsolicited AEs&quot; were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Solicited AEs&quot; included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. &quot;Unsolicited AEs&quot; were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time</measure>
    <time_frame>Days 0, 28, 56, and 196</time_frame>
    <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed. GMTs were calculated using a mixed effects model with treatment (V184 versus placebo), visit and age group, and treatment visit interaction as fixed factors and participant as a random effect. GMFR was defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Chikungunya Virus Infection</condition>
  <arm_group>
    <arm_group_label>V184</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>V184</intervention_name>
    <description>Recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. Liquid frozen, life attenuated, measles vectored V184 vaccine administered via IM injection at 5 × 10^5 TCID50 (+/- 0.5 log) per dose.</description>
    <arm_group_label>V184</arm_group_label>
    <other_name>MV-CHIK</other_name>
    <other_name>MV-CHIK vaccine</other_name>
    <other_name>MV-CHIK/DP (drug product)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sterile physiological saline for IM injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous infection with chikungunya as verified by a serum immunoassay.&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Available and accessible for the duration of the trial.&#xD;
&#xD;
          -  Able and willing to comply with all requirements of the study.&#xD;
&#xD;
          -  For women of childbearing potential, willing to practice adequate contraception for&#xD;
             the duration of the study.&#xD;
&#xD;
          -  Medical history and physical examination findings are considered normal or not&#xD;
             clinically significant in the opinion of the Investigator, which includes resolution&#xD;
             of any arthralgias that may have occurred during prior chikungunya infection, as well&#xD;
             as the absence of synovitis.&#xD;
&#xD;
          -  Laboratory values are considered normal or not clinically significant in the opinion&#xD;
             of the Investigator. If laboratory screening tests are out of the normal reference&#xD;
             range and of potential clinical significance, the test(s) may be repeated up to 2&#xD;
             times (a total of 3 per screening evaluation) at the discretion of the Investigator,&#xD;
             and the repeat values and their potential clinical significance will be used to&#xD;
             determine eligibility.&#xD;
&#xD;
          -  History of immunity to measles. For persons born after 1957, this will be established&#xD;
             by a history of compliance with vaccination policies that included measles vaccination&#xD;
             or known vaccination as an adult at least one month before they are randomized.&#xD;
             Volunteers born before 1957 will be presumed to have immunity to measles based on&#xD;
             natural exposure in accordance with US Centers for Disease Control and Prevention&#xD;
             (CDC) guidelines [McLean 2013].&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking medication or other treatment for unresolved symptoms attributed to a previous&#xD;
             chikungunya virus infection.&#xD;
&#xD;
          -  Prior receipt of any investigational chikungunya or other alphavirus vaccine. To date,&#xD;
             no alphavirus vaccines have been commercially available in the United States.&#xD;
&#xD;
          -  Recent infection:&#xD;
&#xD;
               -  self-limited upper respiratory infections until afebrile without medication for&#xD;
                  &gt;1 week;&#xD;
&#xD;
               -  chikungunya unless/until asymptomatic (other than mild subjective symptoms not&#xD;
                  requiring treatment) for &gt;3 months;&#xD;
&#xD;
               -  non-recurrent upper respiratory or urinary tract infections successfully treated&#xD;
                  with antibiotics, until asymptomatic for 1 month after full antibiotic course has&#xD;
                  been completed.&#xD;
&#xD;
          -  History of an acute allergic or anaphylactic reaction to any vaccine.&#xD;
&#xD;
          -  History of an immunosuppressive disorder (such as human immunodeficiency virus [HIV]&#xD;
             infection, Common Variable Immune Deficiency), chronic infection (such as chronic&#xD;
             hepatitis B or C), autoimmune disease (such as rheumatoid arthritis, systemic lupus&#xD;
             erythematosus (SLE), autoimmune thyroid disease), or any medical condition that, in&#xD;
             the opinion of the Investigator, could lead to an atypical immune response to the&#xD;
             vaccine.&#xD;
&#xD;
          -  History of moderate or severe non-traumatic arthritis or arthralgia within 3 months of&#xD;
             the Screening Visit.&#xD;
&#xD;
          -  Recent (within 30 days), current or anticipated use of any immunosuppressive or immune&#xD;
             modifying medication including corticosteroids (excluding nasal, ophthalmic, and other&#xD;
             topical preparations).&#xD;
&#xD;
          -  Other vaccination or planned vaccination within 4 weeks of either study dose (seasonal&#xD;
             influenza vaccine excepted).&#xD;
&#xD;
          -  Receipt or planned receipt of blood products including immunoglobulins within 120 days&#xD;
             of the Screening Visit.&#xD;
&#xD;
          -  Pregnant or lactating or planning pregnancy during the trial.&#xD;
&#xD;
          -  Known alcohol or other substance abuse that in the opinion of the Investigator affects&#xD;
             the ability or willingness of the participant to understand and comply with the study&#xD;
             protocol.&#xD;
&#xD;
          -  Participation in another clinical study within the past 30 days in which the&#xD;
             participant was exposed to an investigational product (pharmaceutical product or&#xD;
             placebo or device) or planned participation in another interventional clinical study&#xD;
             while participating in this study.&#xD;
&#xD;
          -  Relevant history of any medical condition that, in the opinion of the Investigator,&#xD;
             may interfere with the safety of the participant or aims of the study.&#xD;
&#xD;
          -  History of neoplastic disease (excluding successfully treated non-melanoma skin cancer&#xD;
             or cervical intraepithelial neoplasia) within the past 5 years or a history of any&#xD;
             hematological malignancy.&#xD;
&#xD;
          -  Behavioral or psychiatric disease or cognitive impairment that in the opinion of the&#xD;
             Investigator affects the ability or willingness of the participant to understand and&#xD;
             comply with the study protocol.&#xD;
&#xD;
          -  Non-consent to storage of blood specimens for future research.&#xD;
&#xD;
          -  Persons in direct relationship with the Sponsor or its contracted service providers,&#xD;
             the contract research organisation (CRO) or its subcontractors, the Investigator, or&#xD;
             study site staff. Direct relationship includes first degree relatives or dependents&#xD;
             (children, spouse/partner, siblings or parents), as well as employees (site or&#xD;
             Sponsor).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 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>San Juan Hospital, Research Unit</name>
      <address>
        <city>San Juan</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <results_first_submitted>April 20, 2022</results_first_submitted>
  <results_first_submitted_qc>April 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2022</results_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 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>Chikungunya Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03807843/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>V184</title>
          <description>Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>V184</title>
          <description>Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.2" spread="13.29"/>
                    <measurement group_id="B2" value="37.3" spread="11.37"/>
                    <measurement group_id="B3" value="39.3" spread="12.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Adverse Events (AEs)</title>
        <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Solicited AEs&quot; included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. The number of participants with solicited AEs following Vaccination 1 (Day 0) or Vaccination 2 (Day 28) were reported for each group.</description>
        <time_frame>Up to 7 days after vaccination (up to Day 35)</time_frame>
        <population>All participants that received at least one dose of vaccine/placebo were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V184</title>
            <description>Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Adverse Events (AEs)</title>
          <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Solicited AEs&quot; included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. The number of participants with solicited AEs following Vaccination 1 (Day 0) or Vaccination 2 (Day 28) were reported for each group.</description>
          <population>All participants that received at least one dose of vaccine/placebo were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time</title>
        <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed. GMTs were calculated using a mixed effects model with treatment (V184 versus placebo), visit and age group, and treatment visit interaction as fixed factors and participant as a random effect. GMFR was defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).</description>
        <time_frame>Days 0, 28, 56, and 196</time_frame>
        <population>All participants that received both doses of vaccine/placebo, had at least one post-vaccination immunogenicity assessment, and did not experience a protocol deviation that affected their immunogenicity evaluation were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V184</title>
            <description>Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time</title>
          <description>Serum samples were collected and the titers of serum neutralization antibodies were assessed. GMTs were calculated using a mixed effects model with treatment (V184 versus placebo), visit and age group, and treatment visit interaction as fixed factors and participant as a random effect. GMFR was defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).</description>
          <population>All participants that received both doses of vaccine/placebo, had at least one post-vaccination immunogenicity assessment, and did not experience a protocol deviation that affected their immunogenicity evaluation were analyzed.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.2" upper_limit="1.8"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.7" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.5" upper_limit="2.3"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.7" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 196</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.8" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 28 V184 GMFR/Placebo GMFR Ratio&#xD;
The ratio of V184 GMFR/Placebo GMFR at Day 28 was derived from the mixed effects model used to determine GMFR.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Mixed Effects Model</method>
            <param_type>V184 GMFR/Placebo GMFR Ratio</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.2</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 56 V184 GMFR/Placebo GMFR Ratio&#xD;
The ratio of V184 GMFR/Placebo GMFR at Day 56 was derived from the mixed effects model used to determine GMFR.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Effects Model</method>
            <param_type>V184 GMFR/Placebo GMFR Ratio</param_type>
            <param_value>2.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 196 V184 GMFR/Placebo GMFR Ratio&#xD;
The ratio of V184 GMFR/Placebo GMFR at Day 196 was derived from the mixed effects model used to determine GMFR.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.121</p_value>
            <method>Mixed Effects Model</method>
            <param_type>V184 GMFR/Placebo GMFR Ratio</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited AEs</title>
        <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Unsolicited AEs&quot; were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>All participants that received at least one dose of vaccine/placebo were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V184</title>
            <description>Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited AEs</title>
          <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Unsolicited AEs&quot; were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.</description>
          <population>All participants that received at least one dose of vaccine/placebo were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)</title>
        <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Solicited AEs&quot; included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. &quot;Unsolicited AEs&quot; were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>All participants that received at least one dose of vaccine/placebo were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V184</title>
            <description>Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)</title>
          <description>An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. &quot;Solicited AEs&quot; included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. &quot;Unsolicited AEs&quot; were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.</description>
          <population>All participants that received at least one dose of vaccine/placebo were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 196</time_frame>
      <desc>All-Cause Mortality table includes all randomized participants. Serious and Other AE tables include all randomized participants who received at least 1 dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>V184</title>
          <description>Participants received 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="17" subjects_affected="11" subjects_at_risk="21"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>After completion of the study, the Investigator may prepare a joint publication with the Sponsor and Project Oversight Agency. The Investigator must not submit any part of the data from this protocol for publication without the prior consent of the Sponsor and Project Oversight Agency.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03807843
org study id: V184-006
secondary id: MV-CHIK-206
nct id: NCT03807843
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in
      participants with history of chikungunya infection. Initially 21 to 50 year old participants
      will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be
      enrolled.
This will be a randomized double-blind interventional clinical study. This study proposes to
      evaluate the safety and immunogenicity of the investigational V184 live recombinant
      measles-vectored chikungunya vaccine delivered in 2 vaccinations, 28 days apart compared with
      saline placebo. After providing informed consent, individuals will be screened for
      eligibility including verification of previous exposure to chikungunya virus. They will then
      be randomized in a double-blind fashion to receive either V184 or saline placebo in a 1:1
      ratio.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Placebo-controlled, randomized, double-blinded, interventional, safety study
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Study medication is available as liquid frozen vaccine product or saline for injection (placebo). The actual study injections will be forwarded to the investigator (injector) in a blinded fashion (injection ready syringes containing either vaccine or placebo).
measure: Number of Participants With Solicited Adverse Events (AEs)
time frame: Up to 7 days after vaccination (up to Day 35)
description: An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. The number of participants with solicited AEs following Vaccination 1 (Day 0) or Vaccination 2 (Day 28) were reported for each group.
measure: Number of Participants With Unsolicited AEs
time frame: Up to Day 196
description: An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.
measure: Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)
time frame: Up to Day 196
description: An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.
measure: Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time
time frame: Days 0, 28, 56, and 196
description: Serum samples were collected and the titers of serum neutralization antibodies were assessed. GMTs were calculated using a mixed effects model with treatment (V184 versus placebo), visit and age group, and treatment visit interaction as fixed factors and participant as a random effect. GMFR was defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).
arm group label: V184
arm group type: Experimental
description: Participants will receive 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28.
intervention type: Biological
intervention name: V184
description: Recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. Liquid frozen, life attenuated, measles vectored V184 vaccine administered via IM injection at 5 × 10^5 TCID50 (+/- 0.5 log) per dose.
arm group label: V184
other name: MV-CHIK
other name: MV-CHIK vaccine
other name: MV-CHIK/DP (drug product)
intervention type: Other
intervention name: Placebo
description: Sterile physiological saline for IM injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
country: Puerto Rico
responsible party type: Sponsor
mesh term: Chikungunya Fever
mesh term: Vaccines
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 