<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/NCT01683773</url>
  </required_header>
  <id_info>
    <org_study_id>TB032</org_study_id>
    <nct_id>NCT01683773</nct_id>
  </id_info>
  <brief_title>Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A</brief_title>
  <official_title>A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 Followed by MVA85A in BCG Vaccinated Adults (TB032)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aeras</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Crucell Holland BV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emergent BioSolutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will investigate the administration of two new tuberculosis vaccines, called&#xD;
      AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these&#xD;
      vaccines are given one after the other. The trial will assess the safety of both vaccines and&#xD;
      also their ability to stimulate an immune response within the body. It is hoped that when&#xD;
      these two vaccines are given in sequence, the combined immune response is even better than&#xD;
      when each vaccine is used individually.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Safety of AERAS-402 followed by MVA85A</measure>
    <time_frame>3 months after final vaccination</time_frame>
    <description>To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of AERAS-402 followed by MVA85A</measure>
    <time_frame>12-18 months after first vaccination</time_frame>
    <description>To evaluate and compare the immune responses as described by flow cytometric intracellular cytokine staining, antibody serology, and Elispot assays of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three doses of AERAS-402 (1x10^11 vp intramuscular injection)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AERAS-402</intervention_name>
    <description>Intramuscular needle injection 1x10^11 vp</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <other_name>Ad35 TB-S</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MVA85A</intervention_name>
    <description>Intradermal needle injection 1x10^8 pfu</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <other_name>AERAS-485</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must meet all of the following criteria to enter the trial:&#xD;
&#xD;
          -  Healthy adult aged 18-55 years&#xD;
&#xD;
          -  Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF; and able to travel to&#xD;
             Oxford for vaccinations) for the duration of the trial period&#xD;
&#xD;
          -  No relevant findings in medical history or on physical examination&#xD;
&#xD;
          -  Confirmation of prior vaccination with BCG not less than 6 months prior to projected&#xD;
             trial vaccination date (by visible BCG scar on examination or written documentation)&#xD;
&#xD;
          -  Allow the Investigators to discuss the individual's medical history with their GP&#xD;
&#xD;
          -  Use effective contraception for the duration of the trial period (females only)&#xD;
&#xD;
          -  Refrain from blood donation during the trial&#xD;
&#xD;
          -  Give written informed consent&#xD;
&#xD;
          -  Allow the Investigator to register subject details with a confidential database to&#xD;
             prevent concurrent entry into clinical trials&#xD;
&#xD;
          -  Agrees to avoid elective surgery for the duration of the trial&#xD;
&#xD;
          -  Has a body mass index (BMI) between 18 and 33 (weight/height2) by nomogram&#xD;
&#xD;
          -  Able and willing (in the Investigator's opinion) to comply with all the trial&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects must meet none of the following criteria to enter the trial:&#xD;
&#xD;
          -  Laboratory evidence at screening of latent M. tb infection as indicated by a positive&#xD;
             ELISPOT response to ESAT6 or CFP10 antigens&#xD;
&#xD;
          -  Clinical, radiological, or laboratory evidence of current active TB disease&#xD;
&#xD;
          -  Shared a residence within one year prior to day 0 with an individual on&#xD;
             anti-tuberculosis treatment or with culture- or smear-positive pulmonary tuberculosis&#xD;
&#xD;
          -  Previous treatment for active or latent tuberculosis infection&#xD;
&#xD;
          -  Received a TST within 90 days prior to day 0&#xD;
&#xD;
          -  Received a systemic antibiotic within 14 days prior to day 0&#xD;
&#xD;
          -  Inability to discontinue daily medications other than the following during the trial:&#xD;
             oral contraceptives, vitamins, nonprescription nutritional supplements, aspirin,&#xD;
             antihistamines, antihypertensives, antidepressants, inhaled steroids, bronchodilators,&#xD;
             and any other stable, regular medication not deemed to have an impact on safety or&#xD;
             immunogenicity.&#xD;
&#xD;
          -  Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any&#xD;
             other recombinant MVA or adenoviral vaccine; AERAS-402; or any other investigational&#xD;
             M. tb vaccine&#xD;
&#xD;
          -  Clinically significant history of skin disorder, allergy, immunodeficiency (including&#xD;
             HIV), autoimmune disease, cancer (except BCC or CIS), cardiovascular disease,&#xD;
             gastrointestinal disease, liver disease, renal disease, endocrine disorder,&#xD;
             neurological illness, psychiatric disorder, drug or alcohol abuse&#xD;
&#xD;
          -  History of serious psychiatric condition&#xD;
&#xD;
          -  Concurrent oral or systemic steroid medication or the concurrent use of other&#xD;
             immunosuppressive agents&#xD;
&#xD;
          -  History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any&#xD;
             component of the trial vaccine, including eggs&#xD;
&#xD;
          -  Any abnormality of screening blood or urine tests that is deemed to be clinically&#xD;
             significant or that may compromise the safety of the subject in the triala&#xD;
&#xD;
          -  Positive HBsAg, HCV or HIV antibodies&#xD;
&#xD;
          -  Female currently lactating, confirmed pregnancy or intention to become pregnant during&#xD;
             trial period&#xD;
&#xD;
          -  Use of an investigational medicinal product or non-registered drug, live vaccine, or&#xD;
             medical device other than the trial vaccine for 30 days prior to dosing with the trial&#xD;
             vaccine, or planned use during the trial period&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the three months&#xD;
             preceding the planned trial vaccination date&#xD;
&#xD;
          -  Any other significant disease, disorder, or finding, which, in the opinion of the&#xD;
             Investigator, may either put the subject at risk or may influence the result of the&#xD;
             trial or may affect the subject's ability to participate in the trial&#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>Helen McShane</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Wellcome Trust Clinical Research Facility (WTCRF), University of Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.jenner.ac.uk/clinicaltrials</url>
    <description>The Jenner Institute - Clinical Trials</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tuberculosis</keyword>
  <keyword>Phase I</keyword>
  <keyword>MVA85A</keyword>
  <keyword>AERAS-402</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</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/NCT01683773
org study id: TB032
nct id: NCT01683773
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This trial will investigate the administration of two new tuberculosis vaccines, called
      AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these
      vaccines are given one after the other. The trial will assess the safety of both vaccines and
      also their ability to stimulate an immune response within the body. It is hoped that when
      these two vaccines are given in sequence, the combined immune response is even better than
      when each vaccine is used individually.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Safety of AERAS-402 followed by MVA85A
time frame: 3 months after final vaccination
description: To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events
measure: Immunogenicity of AERAS-402 followed by MVA85A
time frame: 12-18 months after first vaccination
description: To evaluate and compare the immune responses as described by flow cytometric intracellular cytokine staining, antibody serology, and Elispot assays of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults
arm group label: Group A
arm group type: Experimental
description: Two doses of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)
arm group label: Group B
arm group type: Experimental
description: One dose of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)
arm group label: Group C
arm group type: Experimental
description: Three doses of AERAS-402 (1x10^11 vp intramuscular injection)
intervention type: Biological
intervention name: AERAS-402
description: Intramuscular needle injection 1x10^11 vp
arm group label: Group A
arm group label: Group B
arm group label: Group C
other name: Ad35 TB-S
intervention type: Biological
intervention name: MVA85A
description: Intradermal needle injection 1x10^8 pfu
arm group label: Group A
arm group label: Group B
other name: AERAS-485
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helen McShane
role: Principal Investigator
affiliation: University of Oxford
facility: 
facility: 
country: United Kingdom
url: http://www.jenner.ac.uk/clinicaltrials
description: The Jenner Institute - Clinical Trials
responsible party type: Sponsor
mesh term: Tuberculosis