<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/NCT03028441</url>
  </required_header>
  <id_info>
    <org_study_id>15-0038</org_study_id>
    <secondary_id>HHSN272201300015I</secondary_id>
    <nct_id>NCT03028441</nct_id>
  </id_info>
  <brief_title>Phase I Trial of Measles Vectored Chikungungya Vaccine</brief_title>
  <official_title>A Phase 1, Double Blinded, Placebo Controlled, Dose Comparison Trial to Evaluate the Safety, Immunogenicity and Schedule of Measles-Vectored Chikungunya Virus Vaccine (MV-CHIK) in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison&#xD;
      trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3&#xD;
      immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects&#xD;
      aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration&#xD;
      is approximately 8-13 months. The primary objectives are to evaluate the safety and&#xD;
      tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and placebo following two&#xD;
      consecutive intramuscular injections and to assess the CHIKV serum plaque reduction&#xD;
      neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 of&#xD;
      MV-CHIK or placebo on day 29 following the first dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison&#xD;
      trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels (5 x&#xD;
      10^4 or 5 x 10^5 TCID50) and 3 immunization schedules (days 1 and 29, days 1 and 85 or days 1&#xD;
      and 169) will be evaluated. The study will have 6 cohorts, each with 30 subjects, 25 of whom&#xD;
      will receive study vaccine and 5 of whom will receive placebo. Cohorts 1-3 will receive the&#xD;
      low dosage of the lyophilized vaccine product (5 x 10^4 TCID50) and cohorts 4-6 will receive&#xD;
      the high dosage (5 x 10^5 TCID50) of the lyophilized vaccine product. Each subject will&#xD;
      receive two study injections using one of the three dosing schedules outlined above. This&#xD;
      study will enroll up to 180 healthy subjects aged 18 to 45 years (inclusive). Subjects will&#xD;
      be counseled on the study and will then sign an informed consent prior to any study&#xD;
      procedures. Screening will be performed which will include evaluation of medical history,&#xD;
      travel history to countries with known CHIKV circulation, medication history, a physical&#xD;
      examination and safety laboratory evaluations. Study duration is approximately 22 months.&#xD;
      Subject participation duration is approximately 8-13 months. The primary objectives are to&#xD;
      evaluate the safety and tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and&#xD;
      placebo following two consecutive intramuscular injections and to assess the CHIKV serum&#xD;
      plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5&#xD;
      TCID50 of MV-CHIK or placebo on day 29 following the first dose. The secondary objectives are&#xD;
      to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to&#xD;
      5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK and or placebo using three dose schedules (days 1&#xD;
      and 29, days 1 and 85, or days 1 and 169) on day 29 following the second dose, assess CHIKV&#xD;
      serum PRNT50 antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on&#xD;
      days 15, 85 and 169 following the second dose of vaccine, assess the CHIKV serum ELISA&#xD;
      antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 29 following&#xD;
      the first dose of vaccine and days 15, 29, 85 and 169 following the second dose of vaccine,&#xD;
      and to assess the durability of CHIKV serum ELISA and PRNT50 antibody responses to 5 x 10^4&#xD;
      TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 85 (Groups 2+5) and day 169 (Groups 3+6)&#xD;
      following the first dose of vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2017</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">January 17, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CHIKV serum antibody Geometric Mean Titer using PRNT50</measure>
    <time_frame>On Day 29 post dose 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean fold change in PRNT50 anti-CHIKV antibody responses</measure>
    <time_frame>On Day 29 post dose 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of solicited injection site reactions</measure>
    <time_frame>Day 1 through Day 15 following both study injections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of solicited systemic reactions</measure>
    <time_frame>Day 1 through Day 15 following both study injections</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of vaccine-related serious adverse events</measure>
    <time_frame>Day 1-660</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of vaccine-related unsolicited adverse events</measure>
    <time_frame>Day 1 through Day 29 following each study vaccination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using PRNT50 (Plaque Reduction Neutralization Test)</measure>
    <time_frame>On Day 29 post dose 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>anti-CHIKV antibody Geometric Mean Titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5</measure>
    <time_frame>On Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-CHIKV antibody Geometric Mean Titer using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)</measure>
    <time_frame>On Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHIKV serum antibody Geometric Mean Titer using ELISA</measure>
    <time_frame>On Day 29 following the first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHIKV serum ELISA antibody Geometric Mean Titer</measure>
    <time_frame>On Day 15, 29, 85, and 169 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHIKV serum PRNT50 antibody Geometric Mean Titer</measure>
    <time_frame>On Day 15, 85, and 169 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHIKV serum PRNT50 antibody Geometric Mean Titer</measure>
    <time_frame>On Day 29 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean fold change from baseline to CHIKV using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)</measure>
    <time_frame>On Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean fold change from baseline to CHIKV using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)</measure>
    <time_frame>On Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses</measure>
    <time_frame>On Day 15, 29, 85, and 169 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses</measure>
    <time_frame>On Day 29 following the first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses</measure>
    <time_frame>On Day 15, 85, and 169 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses</measure>
    <time_frame>On Day 29 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)</measure>
    <time_frame>On Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)</measure>
    <time_frame>On Day 169</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using ELISA</measure>
    <time_frame>On Day 29 following the first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with at least a 4-fold increase in CHIKV serum ELISA antibody titer</measure>
    <time_frame>On Day 15, 29, 85, and 169 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer</measure>
    <time_frame>On Day 15, 85, and 169 following the second dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer</measure>
    <time_frame>On Day 29 following the second dose</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Chikungunya Virus Infection</condition>
  <arm_group>
    <arm_group_label>Group 1- low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day1 and at Day 29 for 25 subjects, placebo for 5 subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2-low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1 and at Day 85 for 25 subjects, placebo for 5 subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3-low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 -high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1 and at Day 29 for 25 subjects, placebo for 5 subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5-high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 85 for 25 subjects, placebo for 5 subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6-dose-High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Group 1- low dose</arm_group_label>
    <arm_group_label>Group 2-low dose</arm_group_label>
    <arm_group_label>Group 3-low dose</arm_group_label>
    <arm_group_label>Group 4 -high dose</arm_group_label>
    <arm_group_label>Group 5-high dose</arm_group_label>
    <arm_group_label>Group 6-dose-High Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC-CHKVLP059-00-VP</intervention_name>
    <description>Measles-vectored Chikungunya vaccine</description>
    <arm_group_label>Group 1- low dose</arm_group_label>
    <arm_group_label>Group 2-low dose</arm_group_label>
    <arm_group_label>Group 3-low dose</arm_group_label>
    <arm_group_label>Group 4 -high dose</arm_group_label>
    <arm_group_label>Group 5-high dose</arm_group_label>
    <arm_group_label>Group 6-dose-High Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria must be assessed by a clinician licensed to make medical diagnoses.&#xD;
        Subjects must meet all of the following inclusion criteria to participate in this study&#xD;
&#xD;
          1. Males and non-pregnant females between the ages of 18 and 45 years (at study start),&#xD;
             inclusive.&#xD;
&#xD;
          2. Provide written informed consent before initiation of any study procedures.&#xD;
&#xD;
          3. Women of childbearing potential must agree to practice adequate contraception during&#xD;
             the 30 days prior to Day 1, the first injection, through 85 days after the second&#xD;
             study injection. A woman is considered of childbearing potential unless surgically&#xD;
             sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal&#xD;
             (&gt; /= 1 year) or successful Essure placement (permanent, non-surgical, non-hormonal&#xD;
             sterilization) with documented confirmation test at least 3 months after the&#xD;
             procedure. Acceptable birth control methods include but are not limited to: abstinence&#xD;
             from sexual intercourse with men; monogamous relationship with a vasectomized partner;&#xD;
             double-barrier methods (condoms, diaphragms, spermicides; and intrauterine devices);&#xD;
             and licensed hormonal methods.&#xD;
&#xD;
          4. In good health, as judged by the investigator and determined by vital signs, medical&#xD;
             history, and a physical examination. Temperature 37.8°C, heart rate 50-110bpm&#xD;
             (inclusive), systolic blood pressure 85-150 mmHg (inclusive), diastolic blood pressure&#xD;
             55-95 mmHg (inclusive). Subjects may be on chronic or as needed (prn) medications if,&#xD;
             in the opinion of the site principal investigator or appropriate sub-investigator,&#xD;
             they pose no additional risk to subject safety or assessment of reactogenicity and&#xD;
             immunogenicity. NOTE: Athletically trained subjects with a pulse &gt; \= 45 - 49 may be&#xD;
             enrolled if an ECG shows no evidence of first, second or third degree heart block.&#xD;
&#xD;
          5. Screening laboratory values must be within site normal limits, though trace urine&#xD;
             protein is acceptable. Screening labs will include: Blood hemoglobin, White blood cell&#xD;
             (WBC) count, Absolute neutrophil count, Platelets, Creatinine, Aspartate&#xD;
             Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (total), Glucose&#xD;
             (random, must be less than 140), Urine dipstick for protein and glucose (negative to&#xD;
             trace protein are acceptable), Negative HIV 1/2 antibody/antigen test, Hepatitis B&#xD;
             surface antigen (HBsAg), and Hepatitis C virus (HCV) antibody NOTE: Creatinine values&#xD;
             lower than the normal range may be acceptable if the PI or a designated licensed&#xD;
             clinician determines that these laboratory findings are not clinically significant.&#xD;
             HIV and hepatitis C viral load PCR testing may be performed for individuals suspected&#xD;
             of having indeterminate antibody/antigen testing (Sites will use the standard HIV&#xD;
             testing protocol for their institution).&#xD;
&#xD;
          6. Able to understand and comply with planned study procedures and willing to be&#xD;
             available for all study-required procedures, visits and calls for the duration of the&#xD;
             study.&#xD;
&#xD;
          7. Willing to abstain from donating whole blood or blood derivatives until 90 days after&#xD;
             the final study injection.&#xD;
&#xD;
          8. History of measles vaccination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of known chikungunya infection.&#xD;
&#xD;
          2. Previous vaccination with an investigational chikungunya vaccine.&#xD;
&#xD;
          3. Past residence in, or travel for greater than 1 consecutive month within the past 6&#xD;
             months to, a location known to have local CHIKV transmission. (Examples of countries&#xD;
             with local chikungunya virus transmission include, but are not limited to, countries&#xD;
             in sub-Saharan Africa, South Asia, the Indian and Pacific Ocean). Residence in or&#xD;
             travel to Central and South America, the Caribbean, Florida, Puerto Rico and the U.S.&#xD;
             Virgin islands, if prior to 2013, will be permitted.&#xD;
&#xD;
          4. Plan to travel to a location known to have local CHIKV transmission during the course&#xD;
             of the study or history of travel to one of these countries within 30 days prior to&#xD;
             screening. Travel to Florida will be permitted. Those planning travel to Florida will&#xD;
             be provided information on mosquito bite protection.&#xD;
&#xD;
          5. Body temperature &gt;/ =100 °F (&gt;/ =37.8°C) or acute illness within 3 days before study&#xD;
             injection days (subject may be rescheduled).&#xD;
&#xD;
          6. A positive serum or urine pregnancy test at screening or within 24 hours prior to&#xD;
             study injection, women who are planning to become pregnant, or women who are&#xD;
             breastfeeding. If female of childbearing potential as defined in Inclusion Criterion&#xD;
             3. From 30 days prior to entering the study until 85 days after the final study&#xD;
             injection.&#xD;
&#xD;
          7. Any clinically significant acute or chronic medical condition that, in the opinion of&#xD;
             the investigator, would preclude participation. E.g., History of seizure disorders&#xD;
             (other than febrile seizures as an infant), autoimmune disease, immunodeficiency, any&#xD;
             spleen disease, active malignancy, active asthma, known cardiac disease, pulmonary&#xD;
             disease, liver disease, renal disease, unstable or progressive neurological disorders,&#xD;
             diabetes mellitus, and transplant recipients.&#xD;
&#xD;
          8. History of thrombocytopenia, idiopathic thrombocytopenic purpura or other platelet&#xD;
             disorder.&#xD;
&#xD;
          9. A history of chronic arthritis or chronic arthralgia symptoms.&#xD;
&#xD;
         10. Used an immunosuppressive or immunomodulatory drug for 2 or more consecutive weeks&#xD;
             within 6 months prior to the first study injection (nasal and topical steroids are&#xD;
             allowed). Such as &gt;/ =20 mg total dose/day of prednisone orally or &gt; 840 µg of inhaled&#xD;
             beclomethasone.&#xD;
&#xD;
         11. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a&#xD;
             psychiatric condition or previous suicide attempt.&#xD;
&#xD;
         12. A history of treatment for any other psychiatric disorder in the past 3 years that&#xD;
             increases the risk to the subject in the opinion of the investigator Treatment for&#xD;
             mild depression or anxiety using a single antidepressant or anti-anxiety medication&#xD;
             will be allowed so long as the subject has been on stable doses for 3 months.&#xD;
&#xD;
         13. Received immunoglobulin or other blood product within 3 months prior to enrollment or&#xD;
             planned receipt of immunoglobulin or a blood product through study day 169 following&#xD;
             the second dose of vaccine.&#xD;
&#xD;
         14. Received or plan to receive any live licensed vaccines within 4 weeks or inactivated&#xD;
             licensed vaccines within 2 weeks of any study injection.&#xD;
&#xD;
         15. Received or plans to receive measles-containing vaccine within 3 months prior to&#xD;
             enrollment or planned to receive through study day 29 following the second dose of&#xD;
             vaccine. measles, mumps, rubella vaccine.&#xD;
&#xD;
         16. History of anaphylaxis or severe allergic reaction to vaccines or history of allergic&#xD;
             reaction to any components in the MV-CHIK vaccine.&#xD;
&#xD;
         17. Received an experimental or investigational agent within 1 month before study&#xD;
             injections or expectation to receive an experimental agent through 6 months following&#xD;
             the last study injection. Vaccine, drug, biologic, device, blood product, or&#xD;
             medication.&#xD;
&#xD;
         18. Any condition that would, in the opinion of the investigator, place the subject at an&#xD;
             unacceptable injury risk, render him/her unable to meet the requirements of the&#xD;
             protocol, or that may interfere with successful study completion.&#xD;
&#xD;
         19. A history of alcohol or drug abuse during the previous 3 years For example, daily&#xD;
             excessive alcohol or marijuana use or frequent binge drinking as determined by the&#xD;
             investigator.&#xD;
&#xD;
         20. Presence of tattoos that, in the opinion of the investigator, would preclude&#xD;
             evaluation of the injection site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Emory Children's Center - Pediatric Infectious Diseases</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322-1014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa - Vaccine Research and Education Unit</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242-2600</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine - Molecular Virology and Microbiology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-3411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 12, 2017</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>November 25, 2020</last_update_submitted>
  <last_update_submitted_qc>November 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chikungunya</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>Measles</keyword>
  <keyword>Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Measles</mesh_term>
    <mesh_term>Chikungunya Fever</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/NCT03028441
org study id: 15-0038
secondary id: HHSN272201300015I
nct id: NCT03028441
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison
      trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3
      immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects
      aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration
      is approximately 8-13 months. The primary objectives are to evaluate the safety and
      tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and placebo following two
      consecutive intramuscular injections and to assess the CHIKV serum plaque reduction
      neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 of
      MV-CHIK or placebo on day 29 following the first dose.
This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison
      trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels (5 x
      10^4 or 5 x 10^5 TCID50) and 3 immunization schedules (days 1 and 29, days 1 and 85 or days 1
      and 169) will be evaluated. The study will have 6 cohorts, each with 30 subjects, 25 of whom
      will receive study vaccine and 5 of whom will receive placebo. Cohorts 1-3 will receive the
      low dosage of the lyophilized vaccine product (5 x 10^4 TCID50) and cohorts 4-6 will receive
      the high dosage (5 x 10^5 TCID50) of the lyophilized vaccine product. Each subject will
      receive two study injections using one of the three dosing schedules outlined above. This
      study will enroll up to 180 healthy subjects aged 18 to 45 years (inclusive). Subjects will
      be counseled on the study and will then sign an informed consent prior to any study
      procedures. Screening will be performed which will include evaluation of medical history,
      travel history to countries with known CHIKV circulation, medication history, a physical
      examination and safety laboratory evaluations. Study duration is approximately 22 months.
      Subject participation duration is approximately 8-13 months. The primary objectives are to
      evaluate the safety and tolerability of 5 x 10^4 TCID50 and 5 x 10^5 TCID50 MV-CHIK and
      placebo following two consecutive intramuscular injections and to assess the CHIKV serum
      plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10^4 TCID50, 5 x 10^5
      TCID50 of MV-CHIK or placebo on day 29 following the first dose. The secondary objectives are
      to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to
      5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK and or placebo using three dose schedules (days 1
      and 29, days 1 and 85, or days 1 and 169) on day 29 following the second dose, assess CHIKV
      serum PRNT50 antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on
      days 15, 85 and 169 following the second dose of vaccine, assess the CHIKV serum ELISA
      antibody responses to 5 x 10^4 TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 29 following
      the first dose of vaccine and days 15, 29, 85 and 169 following the second dose of vaccine,
      and to assess the durability of CHIKV serum ELISA and PRNT50 antibody responses to 5 x 10^4
      TCID50, 5 x 10^5 TCID50 MV-CHIK or placebo on day 85 (Groups 2+5) and day 169 (Groups 3+6)
      following the first dose of vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: CHIKV serum antibody Geometric Mean Titer using PRNT50
time frame: On Day 29 post dose 1
measure: Mean fold change in PRNT50 anti-CHIKV antibody responses
time frame: On Day 29 post dose 1
measure: The number of solicited injection site reactions
time frame: Day 1 through Day 15 following both study injections
measure: The number of solicited systemic reactions
time frame: Day 1 through Day 15 following both study injections
measure: The number of vaccine-related serious adverse events
time frame: Day 1-660
measure: The number of vaccine-related unsolicited adverse events
time frame: Day 1 through Day 29 following each study vaccination
measure: The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using PRNT50 (Plaque Reduction Neutralization Test)
time frame: On Day 29 post dose 1
measure: anti-CHIKV antibody Geometric Mean Titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5
time frame: On Day 85
measure: Anti-CHIKV antibody Geometric Mean Titer using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
time frame: On Day 169
measure: CHIKV serum antibody Geometric Mean Titer using ELISA
time frame: On Day 29 following the first dose
measure: CHIKV serum ELISA antibody Geometric Mean Titer
time frame: On Day 15, 29, 85, and 169 following the second dose
measure: CHIKV serum PRNT50 antibody Geometric Mean Titer
time frame: On Day 15, 85, and 169 following the second dose
measure: CHIKV serum PRNT50 antibody Geometric Mean Titer
time frame: On Day 29 following the second dose
measure: Mean fold change from baseline to CHIKV using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
time frame: On Day 85
measure: Mean fold change from baseline to CHIKV using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
time frame: On Day 169
measure: Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
time frame: On Day 15, 29, 85, and 169 following the second dose
measure: Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
time frame: On Day 29 following the first dose
measure: Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
time frame: On Day 15, 85, and 169 following the second dose
measure: Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
time frame: On Day 29 following the second dose
measure: The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
time frame: On Day 85
measure: The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
time frame: On Day 169
measure: The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using ELISA
time frame: On Day 29 following the first dose
measure: The proportion of subjects with at least a 4-fold increase in CHIKV serum ELISA antibody titer
time frame: On Day 15, 29, 85, and 169 following the second dose
measure: The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
time frame: On Day 15, 85, and 169 following the second dose
measure: The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
time frame: On Day 29 following the second dose
arm group label: Group 1- low dose
arm group type: Experimental
description: 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day1 and at Day 29 for 25 subjects, placebo for 5 subjects
arm group label: Group 2-low dose
arm group type: Experimental
description: 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1 and at Day 85 for 25 subjects, placebo for 5 subjects
arm group label: Group 3-low dose
arm group type: Experimental
description: 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects
arm group label: Group 4 -high dose
arm group type: Experimental
description: 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1 and at Day 29 for 25 subjects, placebo for 5 subjects
arm group label: Group 5-high dose
arm group type: Experimental
description: 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 85 for 25 subjects, placebo for 5 subjects
arm group label: Group 6-dose-High Dose
arm group type: Experimental
description: 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Group 1- low dose
arm group label: Group 2-low dose
arm group label: Group 3-low dose
arm group label: Group 4 -high dose
arm group label: Group 5-high dose
arm group label: Group 6-dose-High Dose
intervention type: Biological
intervention name: VRC-CHKVLP059-00-VP
description: Measles-vectored Chikungunya vaccine
arm group label: Group 1- low dose
arm group label: Group 2-low dose
arm group label: Group 3-low dose
arm group label: Group 4 -high dose
arm group label: Group 5-high dose
arm group label: Group 6-dose-High Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Measles
mesh term: Chikungunya Fever