<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/NCT02218125</url>
  </required_header>
  <id_info>
    <org_study_id>CR100965</org_study_id>
    <secondary_id>IPCAVD006</secondary_id>
    <secondary_id>HIV-V-A002</secondary_id>
    <nct_id>NCT02218125</nct_id>
  </id_info>
  <brief_title>A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults</brief_title>
  <acronym>MENSCH</acronym>
  <official_title>A Phase I Study of Modified Vaccinia Ankara With Mosaic HIV Inserts in Healthy, HIV-Uninfected Adults, Some of Whom Have Previously Received an Adenovirus Type 26 ENVA.01 Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Crucell Holland BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Military HIV Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Crucell Holland BV</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of Modified Vaccinia&#xD;
      Ankara (MVA) Mosaic vaccine in healthy adult participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I, placebo-controlled (the use of an inactive substance identical in&#xD;
      appearance to the active vaccine), double-blind (neither the participant or study personnel&#xD;
      will know the identity of the treatment administered) study where participants will be&#xD;
      randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA)&#xD;
      Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood&#xD;
      of observer and selection bias, provide control for confounding variables, and aid an&#xD;
      unbiased analysis of the study results. The study will include 4 groups of participants, 2&#xD;
      groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus [rAd]&#xD;
      vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants&#xD;
      will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The&#xD;
      trial comprises a 4-week screening period, a 12-week vaccination period during which&#xD;
      participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week&#xD;
      follow-up period to the final visit at Week 52.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2014</start_date>
  <completion_date type="Actual">November 30, 2015</completion_date>
  <primary_completion_date type="Actual">November 30, 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Participants who Experience Adverse Events Within 28 days After Vaccination</measure>
    <time_frame>For 28 days following vaccination on Day 1 and Day 84</time_frame>
    <description>In addition to the number of participants who experience adverse events within the time frame of 28 days after each vaccination, all adverse events that occur from the signing of the informed consent through to the last study visit (Visit 10 [Day 365]) will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination</measure>
    <time_frame>1 week following vaccination on Day 1 and Day 84</time_frame>
    <description>Reactogenicity symptoms monitored following vaccination will include erythema (redness), induration (hardening), and local pain/tenderness, itching, swelling, or warmth at the site of injection, temperature (fever &gt;37.7 degree Celsius); fatigue (extreme tiredness), headache, myalgia (muscle pain), arthralgia (joint pain), chills, nausea, vomiting, rashes, and itching (general and local)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Humoral Immune Responses</measure>
    <time_frame>4 weeks after the second vaccination</time_frame>
    <description>Humoral immune responses will be evaluated by the detection of env-specific binding antibody.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durability of Immune Response</measure>
    <time_frame>6, 9, and 12 months after the first vaccination</time_frame>
    <description>Determined by humoral immune response assays.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With T-cell Responses Following Vaccination</measure>
    <time_frame>4 weeks after the second vaccination</time_frame>
    <description>T-cell responses to be determined by epitope mapping.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group 1- MVA Mosaic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered Modified Vaccinia Ankara (MVA) Mosaic at Week 0 and at Week 12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 - MVA Mosaic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers previously vaccinated with Ad26.ENVA.01 will be administered MVA Mosaic at Week 0 and at Week 12.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4- Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MVA Mosaic</intervention_name>
    <description>0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.</description>
    <arm_group_label>Group 1- MVA Mosaic</arm_group_label>
    <arm_group_label>Group 3 - MVA Mosaic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.</description>
    <arm_group_label>Group 2 - Placebo</arm_group_label>
    <arm_group_label>Group 4- Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults (determined by medical history, physical examination, and clinical&#xD;
             judgment)&#xD;
&#xD;
          -  HIV uninfected&#xD;
&#xD;
          -  Female participants of child bearing potential must have a negative serum β-human&#xD;
             chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to&#xD;
             each vaccine/placebo administration, practice adequate birth control measures from 28&#xD;
             days prior to the first vaccine/placebo administration through to at least 3 months&#xD;
             after the final vaccine/placebo administration&#xD;
&#xD;
          -  Male participants who are sexually active with a woman of childbearing potential and&#xD;
             has not had a vasectomy must agree to use a double barrier method of birth control,&#xD;
             e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with&#xD;
             occlusive cap (diaphragm or cervical/vault caps) with spermicidal&#xD;
             foam/gel/film/cream/suppository&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed HIV-1/-2 infection&#xD;
&#xD;
          -  Chronic active hepatitis B or hepatitis C or active syphilis infection. Active&#xD;
             syphilis documented by exam or serology unless positive serology is due to past&#xD;
             treated infection&#xD;
&#xD;
          -  Within the 12 months prior to enrollment: a history of newly acquired syphilis,&#xD;
             gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia,&#xD;
             pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis,&#xD;
             proctitis, lymphogranulomavenereum, chancroid, or hepatitis B&#xD;
&#xD;
          -  A woman who is breastfeeding&#xD;
&#xD;
          -  Any clinically significant acute or chronic medical condition that, in the opinion of&#xD;
             the investigator, would preclude participation&#xD;
&#xD;
          -  Major surgery within the 4 weeks prior to study entry or planned major surgery through&#xD;
             the course of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Crucell Holland BV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Crucell Holland BV</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>November 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Human immunodeficiency virus type 1 (HIV-1) infection</keyword>
  <keyword>Acquired immunodeficiency syndrome (AIDS)</keyword>
  <keyword>recombinant adenovirus (rAd) vector-based vaccines</keyword>
  <keyword>Vaccination</keyword>
  <keyword>Ad26.ENVA.01</keyword>
  <keyword>Recombinant</keyword>
  <keyword>Modified Vaccinia Ankara (MVA) vector-based vaccines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccinia</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/NCT02218125
org study id: CR100965
secondary id: IPCAVD006
secondary id: HIV-V-A002
nct id: NCT02218125
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia
      Ankara (MVA) Mosaic vaccine in healthy adult participants.
This is a Phase I, placebo-controlled (the use of an inactive substance identical in
      appearance to the active vaccine), double-blind (neither the participant or study personnel
      will know the identity of the treatment administered) study where participants will be
      randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA)
      Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood
      of observer and selection bias, provide control for confounding variables, and aid an
      unbiased analysis of the study results. The study will include 4 groups of participants, 2
      groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus [rAd]
      vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants
      will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The
      trial comprises a 4-week screening period, a 12-week vaccination period during which
      participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week
      follow-up period to the final visit at Week 52.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Number of Participants who Experience Adverse Events Within 28 days After Vaccination
time frame: For 28 days following vaccination on Day 1 and Day 84
description: In addition to the number of participants who experience adverse events within the time frame of 28 days after each vaccination, all adverse events that occur from the signing of the informed consent through to the last study visit (Visit 10 [Day 365]) will be reported.
measure: The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination
time frame: 1 week following vaccination on Day 1 and Day 84
description: Reactogenicity symptoms monitored following vaccination will include erythema (redness), induration (hardening), and local pain/tenderness, itching, swelling, or warmth at the site of injection, temperature (fever >37.7 degree Celsius); fatigue (extreme tiredness), headache, myalgia (muscle pain), arthralgia (joint pain), chills, nausea, vomiting, rashes, and itching (general and local)
measure: The Number of Participants With Humoral Immune Responses
time frame: 4 weeks after the second vaccination
description: Humoral immune responses will be evaluated by the detection of env-specific binding antibody.
measure: Durability of Immune Response
time frame: 6, 9, and 12 months after the first vaccination
description: Determined by humoral immune response assays.
measure: The Number of Participants With T-cell Responses Following Vaccination
time frame: 4 weeks after the second vaccination
description: T-cell responses to be determined by epitope mapping.
arm group label: Group 1- MVA Mosaic
arm group type: Experimental
description: Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered Modified Vaccinia Ankara (MVA) Mosaic at Week 0 and at Week 12.
arm group label: Group 2 - Placebo
arm group type: Placebo Comparator
description: Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.
arm group label: Group 3 - MVA Mosaic
arm group type: Experimental
description: Healthy volunteers previously vaccinated with Ad26.ENVA.01 will be administered MVA Mosaic at Week 0 and at Week 12.
arm group label: Group 4- Placebo
arm group type: Placebo Comparator
description: Participants previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.
intervention type: Biological
intervention name: MVA Mosaic
description: 0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.
arm group label: Group 1- MVA Mosaic
arm group label: Group 3 - MVA Mosaic
intervention type: Biological
intervention name: Placebo
description: 0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
arm group label: Group 2 - Placebo
arm group label: Group 4- Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Crucell Holland BV Clinical Trial
role: Study Director
affiliation: Crucell Holland BV
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vaccinia