<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/NCT03277456</url>
  </required_header>
  <id_info>
    <org_study_id>FLU008</org_study_id>
    <nct_id>NCT03277456</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1</brief_title>
  <official_title>A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1, Manufactured on the AGE1.CR.pIX Novel Avian Cell Line, in Healthy Adult Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vaccitech (UK) Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vaccitech (UK) Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first in human, phase I, open label study of the MVA viral vector (produced in the&#xD;
      novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP&#xD;
      and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone&#xD;
      intramuscularly as a single dose.&#xD;
&#xD;
      There will be 1 study group and a total of 6 volunteers will be enrolled. Staggered&#xD;
      enrollment will apply for the first three volunteers within the group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">November 2, 2017</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of local reactogenicity following intramuscular injection of MVA-NP+M1</measure>
    <time_frame>7 days post vaccination</time_frame>
    <description>Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of systemic reactogenicity following intramuscular injection of MVA-NP+M1</measure>
    <time_frame>7 days post vaccination</time_frame>
    <description>Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the occurrence of adverse events following intramuscular injection of MVA-NP+M1</measure>
    <time_frame>28 days post vaccination</time_frame>
    <description>Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of safety laboratory assessments following intramuscular injection of MVA-NP+M1</measure>
    <time_frame>28 days post vaccination</time_frame>
    <description>Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serious Adverse Events that occur during the study</measure>
    <time_frame>28 days post vaccination</time_frame>
    <description>Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Human Volunteers</condition>
  <arm_group>
    <arm_group_label>Single intramuscular injection of MVA-NP+M1 vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MVA-NP+M1, a novel vaccine will be administered intramuscular. The total volume given is 0.5ml and the dose given is 1.5E8 pfu. Each volunteer will receive one single injection only over a few seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MVA-NP+M1</intervention_name>
    <description>Intramuscular injection of novel vaccine</description>
    <arm_group_label>Single intramuscular injection of MVA-NP+M1 vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adults aged 18-50&#xD;
&#xD;
          2. Able and willing (in the Investigator's opinion) to comply with all study requirements&#xD;
&#xD;
          3. Willing to allow the investigators to discuss the volunteer's medical history with&#xD;
             their General Practitioner&#xD;
&#xD;
          4. For females only, willingness to practice continuous effective contraception (see&#xD;
             below) during the study and a negative pregnancy test on the day(s) of screening and&#xD;
             vaccination (for women of child bearing potential only)&#xD;
&#xD;
          5. Agreement to refrain from blood donation during the course of the study&#xD;
&#xD;
          6. Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in another research study involving receipt of an investigational&#xD;
             product in the 30 days preceding enrolment, or planned use during the study period&#xD;
&#xD;
          2. Prior receipt of an investigational vaccine likely to impact on interpretation of the&#xD;
             trial data.&#xD;
&#xD;
          3. Administration of immunoglobulins and/or any blood products within the three months&#xD;
             preceding the planned administration of the vaccine candidate&#xD;
&#xD;
          4. 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;
          5. History of allergic disease or reactions likely to be exacerbated by any component of&#xD;
             the vaccine&#xD;
&#xD;
          6. Any history of anaphylaxis in relation to vaccination&#xD;
&#xD;
          7. Pregnancy, lactation or willingness/intention to become pregnant during the study (for&#xD;
             women of child bearing potential only)&#xD;
&#xD;
          8. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in&#xD;
             situ)&#xD;
&#xD;
          9. History of serious psychiatric condition likely to affect participation in the study&#xD;
&#xD;
         10. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior&#xD;
             history of significant bleeding or bruising following IM injections or venepuncture&#xD;
&#xD;
         11. Any other serious chronic illness requiring hospital specialist supervision&#xD;
&#xD;
         12. Suspected or known current alcohol abuse as defined by an alcohol intake of greater&#xD;
             than 42 units every week&#xD;
&#xD;
         13. Suspected or known injecting drug abuse in the 5 years preceding enrolment&#xD;
&#xD;
         14. Seropositive for hepatitis B surface antigen (HBsAg)&#xD;
&#xD;
         15. Seropositive for hepatitis C virus (antibodies to HCV)&#xD;
&#xD;
         16. Any clinically significant abnormal finding on screening biochemistry and haematology&#xD;
             blood tests or urinalysis&#xD;
&#xD;
         17. 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;
&#xD;
         18. Inability of the study team to contact the volunteer's GP to confirm medical history&#xD;
             and safety to participate&#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>Director, The Jenner Institute, Oxford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>November 10, 2017</last_update_submitted>
  <last_update_submitted_qc>November 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03277456
org study id: FLU008
nct id: NCT03277456
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a first in human, phase I, open label study of the MVA viral vector (produced in the
      novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP
      and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone
      intramuscularly as a single dose.

      There will be 1 study group and a total of 6 volunteers will be enrolled. Staggered
      enrollment will apply for the first three volunteers within the group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measure of local reactogenicity following intramuscular injection of MVA-NP+M1
time frame: 7 days post vaccination
description: Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.
measure: Measure of systemic reactogenicity following intramuscular injection of MVA-NP+M1
time frame: 7 days post vaccination
description: Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.
measure: Measure the occurrence of adverse events following intramuscular injection of MVA-NP+M1
time frame: 28 days post vaccination
description: Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.
measure: Assessment of safety laboratory assessments following intramuscular injection of MVA-NP+M1
time frame: 28 days post vaccination
description: Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits
measure: Serious Adverse Events that occur during the study
time frame: 28 days post vaccination
description: Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration
arm group label: Single intramuscular injection of MVA-NP+M1 vaccine
arm group type: Experimental
description: MVA-NP+M1, a novel vaccine will be administered intramuscular. The total volume given is 0.5ml and the dose given is 1.5E8 pfu. Each volunteer will receive one single injection only over a few seconds.
intervention type: Biological
intervention name: MVA-NP+M1
description: Intramuscular injection of novel vaccine
arm group label: Single intramuscular injection of MVA-NP+M1 vaccine
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: Director, The Jenner Institute, Oxford University
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No