<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/NCT02252640</url>
  </required_header>
  <id_info>
    <org_study_id>VAC059</org_study_id>
    <secondary_id>2014-001301-40</secondary_id>
    <nct_id>NCT02252640</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S</brief_title>
  <official_title>A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of Concomitant Administration of the Combination Malaria Vaccine Candidate Regimen of RTS,S/AS01¬B + ChAd63 and MVA Encoding ME-TRAP and Also RTS,S/AS01B Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The PATH Malaria Vaccine Initiative (MVI)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess two types of new malaria vaccines in different&#xD;
      combinations. The study will enable us to assess:&#xD;
&#xD;
        1. The ability of the vaccines to prevent malaria infection.&#xD;
&#xD;
        2. The safety of the vaccines in healthy participants.&#xD;
&#xD;
        3. The response of the human immune system to the vaccines.&#xD;
&#xD;
      We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then&#xD;
      exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under&#xD;
      carefully regulated conditions. We will follow participants closely to observe if and when&#xD;
      they develop malaria. If the vaccine combination provides some protection against malaria,&#xD;
      participants will take longer to develop malaria than usual or will not develop malaria at&#xD;
      all. We will also recruit 4 individuals to be control subjects - these participants won't&#xD;
      receive any vaccinations but will be challenged with malaria.&#xD;
&#xD;
      Vaccinated volunteers who do not develop malaria infection in the blood after being infected&#xD;
      with malaria by mosquito bite the first time may be invited back to be again infected with&#xD;
      malaria in a repeat challenge experiment. This would happen approximately 5-7 months after&#xD;
      the first challenge. The purpose of this second challenge will be to see how long the&#xD;
      protection of the investigational vaccine against malaria lasts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 1/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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.</measure>
    <time_frame>6 months</time_frame>
    <description>Use statistical analysis to compare number of completely protected individuals (those who do not, by Day 23 following sporozoite challenge, develop blood stage infection measured by occurrence of P. falciparum parasitemia, assessed by blood slide)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.</measure>
    <time_frame>6 months</time_frame>
    <description>Occurrence of solicited and unsolicited adverse events will be monitored. Solicited and unsolicited AE data will be collected at each clinic visit. It will be collected from diary cards, clinical review, clinical examination (including observations) and laboratory results. This AE data will be tabulated and frequency, duration and severity of AEs compared between groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity generated in malaria naïve individuals of two different dosing regimens of RTS,S/AS01B given concomitantly with ChAd63/MVA ME-TRAP, and of RTS,S/AS01B alone at either full standard dose or with a reduced third dose.</measure>
    <time_frame>6 months</time_frame>
    <description>To document immunogenicity measures, capturing humoral and cellular immune responses to both ChAd63/MVA ME-TRAP and RTS,S as follows: Anti-CS (RT, C-term, full-length), anti-HBs, and anti-ME-TRAP antibody titers; frequency of CS-specific, HBs-specific, and TRAP and ME specific T cells; ChAd63 neutralizing antibody titers; avidity index of anti-CS antibodies. To undertake exploratory analysis of the correlation of these measures with vaccine efficacy. To, furthermore, undertake an exploratory analysis of transcriptomic correlates of vaccine immunogenicity and efficacy. This may be undertaken by microarray analysis or RNA sequencing or both techniques.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Long term protective efficacy of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B</measure>
    <time_frame>12 months</time_frame>
    <description>Long term efficacy of the Group 1, 2, 3 and 4 vaccination regimens will be assessed by re-challenging any sterilely protected individuals at 5 - 7 months after the first CHMI and comparing the number of re-challengees who develop blood stage infection, and the time between CHMI and blood stage infection, with unvaccinated controls.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Plasmodium Falciparum Malaria</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) &amp; ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) &amp; MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) &amp; MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) &amp; ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) &amp; MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01) &amp; MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Week 11: Controlled Human Malaria Infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Week 31-39: Controlled Human Malaria Infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)</intervention_name>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ChAd63 ME-TRAP (5 x 10^10 vp)</intervention_name>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MVA ME-TRAP (2 x 10^8 pfu)</intervention_name>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults aged 18 to 45 years.&#xD;
&#xD;
          -  Able and willing (in the Investigator's opinion) to comply with all study&#xD;
             requirements.&#xD;
&#xD;
          -  Willing to allow the investigators to discuss the volunteer's medical history with&#xD;
             their General Practitioner.&#xD;
&#xD;
          -  Women only: Must practice continuous effective contraception for the duration of the&#xD;
             study.&#xD;
&#xD;
          -  Agreement to refrain from blood donation during the course of the study and for at&#xD;
             least 3 years after the end of their involvement in the study.&#xD;
&#xD;
          -  Written informed consent to participate in the trial.&#xD;
&#xD;
          -  Reachable (24/7) by mobile phone during the period between Controlled Human Malaria&#xD;
             Infection (CHMI) and completion of antimalarial treatment.&#xD;
&#xD;
          -  Willingness to take a curative anti-malaria regimen following CHMI.&#xD;
&#xD;
          -  For volunteers not living in Oxford: agreement to stay in a hotel room close to the&#xD;
             trial centre during a part of the study (from at least day 6.5 post mosquito bite&#xD;
             until anti-malarial treatment is completed).&#xD;
&#xD;
          -  Answer all questions on the informed consent quiz correctly.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinical malaria (any species).&#xD;
&#xD;
          -  Travel to a malaria endemic region during the study period or within the preceding six&#xD;
             months with significant risk of malaria exposure.&#xD;
&#xD;
          -  Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI&#xD;
             (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin,&#xD;
             erythromycin, fluoroquinolones and azithromycin)&#xD;
&#xD;
          -  Receipt of an investigational product in the 30 days preceding enrolment, or planned&#xD;
             receipt 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. If any volunteers in&#xD;
             Group 1-4 undergo rechallenge, this exclusion criterion does not extend to the&#xD;
             vaccines previously received in this trial&#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 within the past 6 months (inhaled and topical steroids&#xD;
             are allowed).&#xD;
&#xD;
          -  Use of immunoglobulins or blood products within 3 months prior to enrolment.&#xD;
&#xD;
          -  History of allergic disease or reactions likely to be exacerbated by any component of&#xD;
             the vaccine (e.g. egg products, Kathon) or malaria infection.&#xD;
&#xD;
          -  Any history of anaphylaxis post vaccination.&#xD;
&#xD;
          -  History of clinically significant contact dermatitis.&#xD;
&#xD;
          -  History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait&#xD;
             or any haematological condition that could affect susceptibility to malaria infection.&#xD;
&#xD;
          -  Pregnancy, lactation or intention to become pregnant during the study.&#xD;
&#xD;
          -  Use of medications known to cause prolongation of the QT interval and existing&#xD;
             contraindication to the use of Malarone&#xD;
&#xD;
          -  Use of medications known to have a potentially clinically significant interaction with&#xD;
             Riamet and Malarone&#xD;
&#xD;
          -  Any clinical condition known to prolong the QT interval&#xD;
&#xD;
          -  History of cardiac arrhythmia, including clinically relevant bradycardia&#xD;
&#xD;
          -  Disturbances of electrolyte balance, eg, hypokalaemia or hypomagnesaemia&#xD;
&#xD;
          -  Family history of congenital QT prolongation or sudden death&#xD;
&#xD;
          -  Contraindications to the use of all three proposed anti-malarial medications; Riamet,&#xD;
             Malarone and Chloroquine.&#xD;
&#xD;
          -  History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in&#xD;
             situ).&#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 standard UK units every week.&#xD;
&#xD;
          -  Suspected or known injecting drug abuse in the 5 years preceding enrolment.&#xD;
&#xD;
          -  Hepatitis B surface antigen (HBsAg) detected in serum.&#xD;
&#xD;
          -  Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless has taken&#xD;
             part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior&#xD;
             to participation in that study, and negative HCV RNA PCR at screening for this study).&#xD;
&#xD;
          -  An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by&#xD;
             the Systematic Coronary Risk Evaluation (SCORE) system.59&#xD;
&#xD;
          -  Positive family history in 1st and 2nd degree relatives &lt;50 years old for cardiac&#xD;
             disease.&#xD;
&#xD;
          -  Volunteers unable to be closely followed for social, geographic or psychological&#xD;
             reasons.&#xD;
&#xD;
          -  Any clinically significant abnormal finding on biochemistry or haematology blood&#xD;
             tests, urinalysis or clinical examination. In the event of abnormal test results,&#xD;
             confirmatory repeat tests will be requested.&#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 the study data.&#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>
  <overall_official>
    <last_name>Adrian VS Hill</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NIHR WTCRF, University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surrey Clinical Research Centre, University of Surrey</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital, Imperial College NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>December 2, 2015</last_update_submitted>
  <last_update_submitted_qc>December 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plasmodium Falciparum</keyword>
  <keyword>Malaria</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Plasmodium</keyword>
  <keyword>Falciparum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Malaria, Falciparum</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/NCT02252640
org study id: VAC059
secondary id: 2014-001301-40
nct id: NCT02252640
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess two types of new malaria vaccines in different
      combinations. The study will enable us to assess:

        1. The ability of the vaccines to prevent malaria infection.

        2. The safety of the vaccines in healthy participants.

        3. The response of the human immune system to the vaccines.

      We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then
      exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under
      carefully regulated conditions. We will follow participants closely to observe if and when
      they develop malaria. If the vaccine combination provides some protection against malaria,
      participants will take longer to develop malaria than usual or will not develop malaria at
      all. We will also recruit 4 individuals to be control subjects - these participants won't
      receive any vaccinations but will be challenged with malaria.

      Vaccinated volunteers who do not develop malaria infection in the blood after being infected
      with malaria by mosquito bite the first time may be invited back to be again infected with
      malaria in a repeat challenge experiment. This would happen approximately 5-7 months after
      the first challenge. The purpose of this second challenge will be to see how long the
      protection of the investigational vaccine against malaria lasts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Efficacy of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.
time frame: 6 months
description: Use statistical analysis to compare number of completely protected individuals (those who do not, by Day 23 following sporozoite challenge, develop blood stage infection measured by occurrence of P. falciparum parasitemia, assessed by blood slide)
measure: Safety of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B against malaria sporozoite challenge.
time frame: 6 months
description: Occurrence of solicited and unsolicited adverse events will be monitored. Solicited and unsolicited AE data will be collected at each clinic visit. It will be collected from diary cards, clinical review, clinical examination (including observations) and laboratory results. This AE data will be tabulated and frequency, duration and severity of AEs compared between groups.
measure: Immunogenicity generated in malaria naïve individuals of two different dosing regimens of RTS,S/AS01B given concomitantly with ChAd63/MVA ME-TRAP, and of RTS,S/AS01B alone at either full standard dose or with a reduced third dose.
time frame: 6 months
description: To document immunogenicity measures, capturing humoral and cellular immune responses to both ChAd63/MVA ME-TRAP and RTS,S as follows: Anti-CS (RT, C-term, full-length), anti-HBs, and anti-ME-TRAP antibody titers; frequency of CS-specific, HBs-specific, and TRAP and ME specific T cells; ChAd63 neutralizing antibody titers; avidity index of anti-CS antibodies. To undertake exploratory analysis of the correlation of these measures with vaccine efficacy. To, furthermore, undertake an exploratory analysis of transcriptomic correlates of vaccine immunogenicity and efficacy. This may be undertaken by microarray analysis or RNA sequencing or both techniques.
measure: Long term protective efficacy of a combination immunization regimen with ChAd63/MVA ME-TRAP given concomitantly with RTS,S/AS01B
time frame: 12 months
description: Long term efficacy of the Group 1, 2, 3 and 4 vaccination regimens will be assessed by re-challenging any sterilely protected individuals at 5 - 7 months after the first CHMI and comparing the number of re-challengees who develop blood stage infection, and the time between CHMI and blood stage infection, with unvaccinated controls.
arm group label: Group 1
arm group type: Active Comparator
description: Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
arm group label: Group 2
arm group type: Active Comparator
description: Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
arm group label: Group 3
arm group type: Active Comparator
description: Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) & ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) & MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) & MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
arm group label: Group 4
arm group type: Active Comparator
description: Week 0: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) & ChAd63 ME-TRAP (5 x 10^10 vp), Week 4: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01) & MVA ME-TRAP (2 x 10^8 pfu), Week 8: RTS,S/AS01B (10mcg of RTS,S and 1/5 of the standard dose of AS01) & MVA ME-TRAP (2 x 10^8 pfu), Week 11: Controlled Human Malaria Infection (CHMI), Week 31-39: Repeat CHMI of sterilely protected volunteers.
arm group label: Group 5
arm group type: No Intervention
description: Week 11: Controlled Human Malaria Infection
arm group label: Group 6
arm group type: No Intervention
description: Week 31-39: Controlled Human Malaria Infection
intervention type: Biological
intervention name: RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
intervention type: Biological
intervention name: RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)
arm group label: Group 2
arm group label: Group 4
intervention type: Biological
intervention name: ChAd63 ME-TRAP (5 x 10^10 vp)
arm group label: Group 3
arm group label: Group 4
intervention type: Biological
intervention name: MVA ME-TRAP (2 x 10^8 pfu)
arm group label: Group 3
arm group label: Group 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adrian VS Hill
role: Principal Investigator
affiliation: University of Oxford
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Malaria
mesh term: Malaria, Falciparum