<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/NCT01677676</url>
  </required_header>
  <id_info>
    <org_study_id>FP-01.1_CS_02</org_study_id>
    <nct_id>NCT01677676</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)</brief_title>
  <official_title>A Randomised, Double-Blind, Double Observer, Study to Assess the Safety, Tolerability and Immunogenicity of Repeated Intramuscular Administration of Two Different Formulations of an Influenza A Vaccine (FP-01.1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immune Targeting Systems Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INCResearch Australia Pty Limited</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Immune Targeting Systems Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study has been designed to evaluate the safety and immunogenicity of two different&#xD;
      formulations of FP-01.1 as well as build on the data set from the first in human study&#xD;
      FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best&#xD;
      formulation of the vaccine to evaluate in efficacy studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and proportion of subjects reporting solicited local reactions and severity of the local reactions</measure>
    <time_frame>Day 1-57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess and compare the immunogenicity response between groups</measure>
    <time_frame>Day 1-57</time_frame>
    <description>The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and proportion of subjects reporting solicited systemic events</measure>
    <time_frame>Day 1-57, optional safety FU day 209</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)</measure>
    <time_frame>Day 1-57, optional safety follow up at day 209</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments</measure>
    <time_frame>Day 1-57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and proportion of subjects with abnormal vital signs/ECG assessments</measure>
    <time_frame>Day 1-57</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exploratory immunogenicity tests on samples obtained from subjects</measure>
    <time_frame>Day 1-57</time_frame>
    <description>Additional assessment of T cell responses induced by the vaccine including virus strain cross reactivity and intracellular cytokine staining assays.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Influenza A</condition>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FP-01.1 (250µg/peptide)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FP-01.1-Adjuvant (150µg/peptide / 10.8mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FP-01.1-Adjuvant (250µg/peptide / 18mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FP-01.1 (150µg/peptide)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1</intervention_name>
    <description>IM injection</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>Flunisyn</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FP-01.1-Adjuvant</intervention_name>
    <description>IM injection</description>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <other_name>Flunisyn + Adjuvant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 55 years inclusive at the time of consent&#xD;
&#xD;
          2. Willing to comply with the applicable contraceptive requirements of the protocol&#xD;
&#xD;
             • For male subjects, agreement to use a barrier method (condom) as a method of birth&#xD;
             control in addition to any contraceptive measures normally taken by his partner until&#xD;
             completion of the Day 57 visit, and refrain from fathering a child at least until&#xD;
             completion ofthe Day 57 visit. Male subjects do not need to use contraception if their&#xD;
             partner has been through the menopause, or has had her womb or both her ovaries&#xD;
             removed.&#xD;
&#xD;
             OR&#xD;
&#xD;
             • For female subjects of childbearing potential, be surgically sterile or using an&#xD;
             insertable, injectable, transdermal, or combination oral contraceptive approved by the&#xD;
             TGA combined with a barrier contraceptive through to completion of the Day 57 visit&#xD;
             study and have negative results on a serum or urine pregnancy test done before&#xD;
             administration of study medication (women who are postmenopausal [no menses for at&#xD;
             least 2 years] are also eligible to participate)&#xD;
&#xD;
          3. Satisfactory medical assessment with no clinically significant or relevant&#xD;
             abnormalities in medical history, physical examination, vital signs, ECG and&#xD;
             laboratory evaluation (haematology, biochemistry or urinalysis) as assessed by the&#xD;
             Investigator.&#xD;
&#xD;
          4. An understanding, ability and willingness to fully comply with study procedures and&#xD;
             restrictions&#xD;
&#xD;
          5. Ability to provide written, personally signed and dated informed consent to&#xD;
             participate in the study.&#xD;
&#xD;
          6. The subject has a body mass index (BMI) within the range 19.0-32.0 kg/m2 and falls&#xD;
             within the weight range of 50.0-100.0 kg.&#xD;
&#xD;
          7. The subject is willing to present a study prepared letter to a General Practitioner&#xD;
             (GP) if visiting for any purpose&#xD;
&#xD;
          8. Subject is willing to refrain from consuming alcohol for 24h prior to all visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. As a result of the medical screening process, the Principal Investigator or&#xD;
             Co-Investigator considers the subject unfit for the study.&#xD;
&#xD;
          2. Current, chronic or recurrent disease (e.g. cardiovascular, respiratory, endocrine,&#xD;
             renal, liver, gastrointestinal, autoimmune, immune suppression, malignancy or other&#xD;
             conditions) that could affect the action, absorption or disposition of the IMP or&#xD;
             could affect clinical or laboratory assessments.&#xD;
&#xD;
          3. Significant illness as judged by the Principal Investigator or Co-Investigator within&#xD;
             2 weeks of the first dose of IMP.&#xD;
&#xD;
          4. Subjects with a history of allergies or allergic conditions including anaphylactic&#xD;
             reactions, asthmatics, hay fever and eczema sufferers requiring medication which in&#xD;
             the opinion of the Principal Investigator or Co-Investigator will affect their&#xD;
             participation in the study.&#xD;
&#xD;
          5. Subjects receiving medications that affect the immune system including systemic&#xD;
             steroids and patients on chronic medications where the dose has not been stable for at&#xD;
             least 3 months.&#xD;
&#xD;
          6. Known or suspected intolerance or hypersensitivity to the IMP, or closely related&#xD;
             compounds or any of the stated ingredients&#xD;
&#xD;
          7. History of alcohol or other substance abuse within the last year. A positive screen&#xD;
             for alcohol or drugs of abuse.&#xD;
&#xD;
          8. Male subjects who consume more than 21 units of alcohol per week and female subjects&#xD;
             who consume more than 14 units of alcohol per week.&#xD;
&#xD;
          9. A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core&#xD;
             antibody, or Hepatitis C antibody screen&#xD;
&#xD;
         10. Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that&#xD;
             in the opinion of the Investigator could interfere with evaluation of injection site&#xD;
             local reactions, over the deltoid region of both arms as these will be the dose site.&#xD;
&#xD;
         11. Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to&#xD;
             or intention to donate blood during the entire study.&#xD;
&#xD;
         12. Use of another investigational medicinal product within 90 days prior to receiving the&#xD;
             first dose of IMP or intention to enrol in another clinical study throughout the&#xD;
             entire study (up to and including Day 57), including the 6 month follow-up period for&#xD;
             those subjects who consent to remain on study for this follow-up.&#xD;
&#xD;
         13. Subject with suspected recent (≤12 months) pre-exposure to the influenza A virus - flu&#xD;
             like symptoms associated with ≥ 2 days off normal daily activities&#xD;
&#xD;
         14. Subjects who have received a flu vaccine in the last 12 months or who anticipate&#xD;
             receiving it within the duration of the clinical phase of the study (ie up to&#xD;
             completion of Day 57) or the period up to the 6 month safety follow-up telephone call,&#xD;
             for the subjects who consent to remain on study for this follow-up.&#xD;
&#xD;
         15. Any clinically significant abnormalities, in the opinion of the Principal Investigator&#xD;
             or Co-Investigator, on electrocardiograms (ECGs), as assessed against the clinical&#xD;
             site's reference range.&#xD;
&#xD;
        In addition, for each subject, a completed medical history questionnaire will be taken as&#xD;
        part of the consented study procedure.&#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>Joanne Marjason</last_name>
    <role>Principal Investigator</role>
    <affiliation>Q-Pharm Pty Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Q-Pharm Pty Ltd</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>July 26, 2013</last_update_submitted>
  <last_update_submitted_qc>July 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</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/NCT01677676
org study id: FP-01.1_CS_02
nct id: NCT01677676
lead sponsor: 
collaborator: 
has dmc: Yes
This study has been designed to evaluate the safety and immunogenicity of two different
      formulations of FP-01.1 as well as build on the data set from the first in human study
      FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best
      formulation of the vaccine to evaluate in efficacy studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
time frame: Day 1-57
measure: To assess and compare the immunogenicity response between groups
time frame: Day 1-57
description: The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group
measure: Number and proportion of subjects reporting solicited systemic events
time frame: Day 1-57, optional safety FU day 209
measure: Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)
time frame: Day 1-57, optional safety follow up at day 209
measure: Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
time frame: Day 1-57
measure: Number and proportion of subjects with abnormal vital signs/ECG assessments
time frame: Day 1-57
measure: Exploratory immunogenicity tests on samples obtained from subjects
time frame: Day 1-57
description: Additional assessment of T cell responses induced by the vaccine including virus strain cross reactivity and intracellular cytokine staining assays.
arm group label: Group 2
arm group type: Active Comparator
description: FP-01.1 (250µg/peptide)
arm group label: Group 3
arm group type: Active Comparator
description: FP-01.1-Adjuvant (150µg/peptide / 10.8mg)
arm group label: Group 4
arm group type: Active Comparator
description: FP-01.1-Adjuvant (250µg/peptide / 18mg)
arm group label: Group 1
arm group type: Active Comparator
description: FP-01.1 (150µg/peptide)
intervention type: Biological
intervention name: FP-01.1
description: IM injection
arm group label: Group 1
arm group label: Group 2
other name: Flunisyn
intervention type: Biological
intervention name: FP-01.1-Adjuvant
description: IM injection
arm group label: Group 3
arm group label: Group 4
other name: Flunisyn + Adjuvant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joanne Marjason
role: Principal Investigator
affiliation: Q-Pharm Pty Ltd
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Influenza, Human