<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/NCT01669512</url>
  </required_header>
  <id_info>
    <org_study_id>VAC048</org_study_id>
    <nct_id>NCT01669512</nct_id>
  </id_info>
  <brief_title>Adjuvanting Viral Vectored Malaria Vaccines With Matrix M</brief_title>
  <official_title>Safety and Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP Heterologous Prime Boost Malaria Vaccination Adjuvanted With Matrix M™</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied&#xD;
      in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated&#xD;
      viruses which have been modified so that they cannot reproduce in humans. Genetic information&#xD;
      has been added to make them express proteins of the malaria parasite so that they stimulate&#xD;
      an immune response against malaria. This trial examines whether a compound called Matrix M™&#xD;
      can be used in efforts to improve on how well the vaccines work at preventing malaria.&#xD;
&#xD;
      Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines.&#xD;
      In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to&#xD;
      assess the safety of the vaccines when combined with Matrix M™, and to determine what effect&#xD;
      Matrix M™ has on the immune responses to the vaccines.&#xD;
&#xD;
      We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA&#xD;
      METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring&#xD;
      them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of&#xD;
      Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six&#xD;
      volunteers will receive the vaccines alone as a comparison group. We will also look at what&#xD;
      effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests.&#xD;
      Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical&#xD;
      Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have&#xD;
      blood taken to monitor safety and measure immune responses to vaccination, and be monitored&#xD;
      for symptoms/side effects from vaccination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the safety of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination adjuvanted with Matrix M™</measure>
    <time_frame>24 weeks from first vaccination</time_frame>
    <description>Analysis of all solicited and unsolicited local and general vaccine-linked adverse events (AEs) occurring in Low Dose Matrix M™ and Standard Dose Matrix M™ Group volunteers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the effects of Matrix M™ on the immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination</measure>
    <time_frame>24 weeks from first vaccination</time_frame>
    <description>Comparison of immunogenicity of the Matrix M™ - adjuvanted vaccination regimens, versus the Control regimen.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Malaria</condition>
  <condition>Matrix M</condition>
  <arm_group>
    <arm_group_label>Control Regimen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56 6 Volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose Matrix M Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56 8 Volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Dose Matrix M Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56 8 Volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Control Regimen</intervention_name>
    <description>ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56</description>
    <arm_group_label>Control Regimen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low Dose Matrix M Regimen</intervention_name>
    <description>ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56</description>
    <arm_group_label>Low Dose Matrix M Regimen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Standard Dose Matrix M Regimen</intervention_name>
    <description>ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56</description>
    <arm_group_label>Standard Dose Matrix M Regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult aged 18 to 50 years&#xD;
&#xD;
          -  Able and willing (in the Investigator's opinion) to comply with all study requirements&#xD;
&#xD;
          -  Willing to allow the investigators to discuss their medical history with their General&#xD;
             Practitioner&#xD;
&#xD;
          -  For female volunteers, willingness to practice continuous effective contraception&#xD;
             during the study&#xD;
&#xD;
          -  For male volunteers, must use barrier contraception for 3 months from the day of any&#xD;
             administration of Matrix M™&#xD;
&#xD;
          -  Agreement to refrain from blood donation during the course of the study and for 6&#xD;
             months after the end of their involvement in the study&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another research study involving an investigational product in the 30&#xD;
             days preceding enrolment, or planned use during the study period&#xD;
&#xD;
          -  Prior receipt of an investigational malaria vaccine or any other investigational&#xD;
             vaccine likely to impact on interpretation of the trial data&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the three months&#xD;
             preceding the planned administration of the vaccine candidate&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV&#xD;
             infection; asplenia; recurrent, severe infections; and chronic (more than 14 days)&#xD;
             immunosuppressant medication use within the past 6 months (inhaled and topical&#xD;
             steroids are allowed)&#xD;
&#xD;
          -  Pregnancy, lactation, or intention to become pregnant during the study&#xD;
&#xD;
          -  History of allergic disease or reactions likely to be exacerbated by any component of&#xD;
             the vaccine, e.g. egg products, Kathon&#xD;
&#xD;
          -  History of clinically significant contact dermatitis Any history of anaphylaxis or&#xD;
             hypersensitivity in relation to vaccination&#xD;
&#xD;
          -  History or evidence of pre-existing autoimmune or antibody-mediated disease or&#xD;
             laboratory evidence of possible autoimmune disease, defined as a positive antinuclear&#xD;
             antibody (ANA) result at screening.&#xD;
&#xD;
          -  Any history of malaria&#xD;
&#xD;
          -  Travel to a malaria endemic region during the study period or within the six months&#xD;
             preceding enrolment in the study with significant risk of malaria infection&#xD;
&#xD;
          -  History of serious psychiatric condition that may affect participation in the study&#xD;
&#xD;
          -  Any other serious chronic illness requiring hospital specialist supervision&#xD;
&#xD;
          -  Suspected or known current alcohol abuse as defined by an alcohol intake of greater&#xD;
             than 42 units every week&#xD;
&#xD;
          -  Suspected or known injecting drug abuse in the five years preceding enrolment&#xD;
&#xD;
          -  Seropositive for hepatitis B surface antigen (HBsAg)&#xD;
&#xD;
          -  Seropositive for hepatitis C virus (antibodies to HCV)&#xD;
&#xD;
          -  Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical&#xD;
             carcinoma in situ)&#xD;
&#xD;
          -  Any clinically significant abnormal finding on screening biochemistry or haematology&#xD;
             blood tests or urinalysis&#xD;
&#xD;
          -  Any other significant disease, disorder or finding which may significantly increase&#xD;
             the risk to the volunteer because of participation in the study, affect the ability of&#xD;
             the volunteer to participate in the study or impair interpretation of study data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Hill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Clinical Vaccinology and Tropical Medicine</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>January 6, 2015</last_update_submitted>
  <last_update_submitted_qc>January 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malaria vaccine</keyword>
  <keyword>Matrix M</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</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/NCT01669512
org study id: VAC048
nct id: NCT01669512
lead sponsor: 
has dmc: No
ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been studied
      in clinical trials for 4 years, and 10 years, respectively. These vaccines are inactivated
      viruses which have been modified so that they cannot reproduce in humans. Genetic information
      has been added to make them express proteins of the malaria parasite so that they stimulate
      an immune response against malaria. This trial examines whether a compound called Matrix M™
      can be used in efforts to improve on how well the vaccines work at preventing malaria.

      Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines.
      In this trial, Matrix M™ will be combined with each of the vaccines. The objectives are to
      assess the safety of the vaccines when combined with Matrix M™, and to determine what effect
      Matrix M™ has on the immune responses to the vaccines.

      We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA
      METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring
      them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of
      Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six
      volunteers will receive the vaccines alone as a comparison group. We will also look at what
      effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests.
      Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical
      Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have
      blood taken to monitor safety and measure immune responses to vaccination, and be monitored
      for symptoms/side effects from vaccination.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To assess the safety of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination adjuvanted with Matrix M™
time frame: 24 weeks from first vaccination
description: Analysis of all solicited and unsolicited local and general vaccine-linked adverse events (AEs) occurring in Low Dose Matrix M™ and Standard Dose Matrix M™ Group volunteers.
measure: Assess the effects of Matrix M™ on the immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination
time frame: 24 weeks from first vaccination
description: Comparison of immunogenicity of the Matrix M™ - adjuvanted vaccination regimens, versus the Control regimen.
arm group label: Control Regimen
arm group type: Active Comparator
description: ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56 6 Volunteers
arm group label: Low Dose Matrix M Regimen
arm group type: Experimental
description: ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56 8 Volunteers
arm group label: Standard Dose Matrix M Regimen
arm group type: Experimental
description: ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56 8 Volunteers
intervention type: Biological
intervention name: Control Regimen
description: ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56
arm group label: Control Regimen
intervention type: Biological
intervention name: Low Dose Matrix M Regimen
description: ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56
arm group label: Low Dose Matrix M Regimen
intervention type: Biological
intervention name: Standard Dose Matrix M Regimen
description: ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56
arm group label: Standard Dose Matrix M Regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adrian Hill, MD
role: Principal Investigator
affiliation: University of Oxford
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Malaria