<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/NCT03270800</url>
  </required_header>
  <id_info>
    <org_study_id>2015-004761-82</org_study_id>
    <nct_id>NCT03270800</nct_id>
  </id_info>
  <brief_title>Phase 1a/b Study on Safety of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers</brief_title>
  <acronym>IMX-02</acronym>
  <official_title>A Randomized, Double-blind, Adjuvant-controlled Phase 1a/b Study on Safety and Tolerability With Ascending Multiple Doses of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ImevaX</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ImevaX</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>
      A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate&#xD;
      the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected&#xD;
      healthy volunteers.&#xD;
&#xD;
      The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each&#xD;
      containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts&#xD;
      will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to&#xD;
      one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each&#xD;
      cohort.&#xD;
&#xD;
      Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in&#xD;
      each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the&#xD;
      DSMB, as soon as the results of the safety and efficacy analyses are available.&#xD;
&#xD;
      Up to 72 subjects collectively in Phases A &amp; B will be recruited. depending on immunogenicity&#xD;
      status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">December 23, 2018</completion_date>
  <primary_completion_date type="Actual">December 23, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability of IMX101</measure>
    <time_frame>215 days</time_frame>
    <description>All subjects who received at least one dose of the IMP will be included in the safety analysis by following parameters:&#xD;
-Adverse events: AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA). Separate analyses will be conducted using severity, seriousness, and relationship to the IMP. Treatment-emergent adverse events (TEAEs) will be summarised and tabulated according to the primary system organ class and preferred term.&#xD;
Clinical laboratory and other safety measures Haematology and clinical chemistry will be summarised with descriptive statistics for absolute values und changes from Baseline by visit. Urine dipstick test will be summarised with frequency tables by visit.&#xD;
Vital signs Vital signs will be summarised with descriptive statistics for absolute values und changes from Baseline by visit.&#xD;
Local tolerability Injection site assessments will be summarised in frequency tables when the collected data allow for this.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of immune Responses</measure>
    <time_frame>215 days</time_frame>
    <description>Humoral and cellular immune Response towards IMX101 and detection of inhibitory antibodies&#xD;
Secondary Endpoint(s):&#xD;
Detection of vaccine-antigen specific antibodies by Enzyme linked immunosorbent assay (ELISA) at V6, V7, V8 and V9 in the non-infected subjects and at V6, V7, V8, V9, V10 and V11 in the H.pylori infected subjects.&#xD;
Detection of inhibitory antibodies blocking H.pylori gGT enzymatic activity at V6, V7, V8 and V9 in the non-infected subjects and at V6, V7, V8, V9, V10 and V11 in the H.pylori-infected subjects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Helicobacter Pylori Infected Subjects</condition>
  <condition>Helicobacter Pylori Naive Subjects</condition>
  <arm_group>
    <arm_group_label>IMX101 vaccine as intradermal and sublingual application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMX101 vaccine will be administered intradermally and sublingually</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTA control as intradermal and sublingual application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CTA mucosal adjuvans will be administered intradermally and sublingually</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CTA control</intervention_name>
    <description>Sublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market.</description>
    <arm_group_label>CTA control as intradermal and sublingual application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IMX101 vaccine</intervention_name>
    <description>Sublingual and intradermal application of a vaccine, drug product is not yet on the market.</description>
    <arm_group_label>IMX101 vaccine as intradermal and sublingual application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  H. pylori-infected subjects: Confirmed H. pylori infection by urea breath test and&#xD;
             serology.&#xD;
&#xD;
        H. pylori-negative subjects: Presenting no H. pylori infection by urea breath test and&#xD;
        serology.&#xD;
&#xD;
          -  Men and women aged ≥18 years and ≤ 50 years.&#xD;
&#xD;
          -  Female subjects must either be of non-childbearing potential or use highly effective&#xD;
             methods of contraception for at least 1 month prior to Screening and 1 month after end&#xD;
             of study participation (see section pregnancy and contraceptives).&#xD;
&#xD;
          -  Women with a negative serum test at Screening (V2) and women of childbearing potential&#xD;
             additionally with a negative urine pregnancy test at each visit (except V1 and FU&#xD;
             V10/V12).&#xD;
&#xD;
          -  Have given written informed consent prior to admission to the study in accordance with&#xD;
             ICH-GCP and local legislation.&#xD;
&#xD;
          -  Ability to comply with the requirements of the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of successful treatment for H. pylori infection.&#xD;
&#xD;
          -  Regular use (once a week or more) of diclofenac, other non-steroidal anti-inflammatory&#xD;
             drugs (NSAIDs), e.g. acetylsalicylic acid (Aspirin®), or proton pump inhibitor (PPI).&#xD;
             Additionally, PPI is used within 2 weeks prior to V1 and V11.&#xD;
&#xD;
          -  Use of anticoagulants (i.e. heparin, coumarin derivatives, e.g. Marcumar®).&#xD;
&#xD;
          -  Use of antibiotics employed in H. pylori therapy within the month prior to study entry&#xD;
             (V1) as well as 1 month prior to each endoscopy (V3 and V9/V11).&#xD;
&#xD;
          -  Recent or current (within the last 6 months) systemic corticosteroid use including&#xD;
             inhaled corticosteroids. Topical corticosteroid medication is allowed.&#xD;
&#xD;
          -  Current or previous gastric ulcer diseases or preneoplastic changes in the stomach&#xD;
             mucosa according to medical records or endoscopy findings confirmed by histological&#xD;
             assessment at Baseline (V3).&#xD;
&#xD;
          -  Current or previous medically significant gastroduodenal disease.&#xD;
&#xD;
          -  Preceding cholera immunisation or disease.&#xD;
&#xD;
          -  Uncontrolled hypertension or orthostatic hypotension.&#xD;
&#xD;
          -  Body mass index (BMI) ≤ 18 or ≥ 30.&#xD;
&#xD;
          -  Poorly-controlled type I or type II diabetes mellitus (glycosylated haemoglobin&#xD;
             [HbA1c] ≥ 7.5% within the last 6 weeks) and subjects requiring insulin treatment.&#xD;
&#xD;
          -  History, evidence or suspicion of tumour burden.&#xD;
&#xD;
          -  Epilepsy or seizure disorder.&#xD;
&#xD;
          -  Bleeding diathesis.&#xD;
&#xD;
          -  Positive viral serology screening result for hepatitis B surface antigen (HBS Ag),&#xD;
             antibodies to hepatitis C virus (HCV Ab), or human immunodeficiency virus (HIV) type 1&#xD;
             and 2.&#xD;
&#xD;
          -  Known significant allergic reaction to any drug as determined by the investigator,&#xD;
             such as anaphylaxis requiring hospitalisation.&#xD;
&#xD;
          -  A history of active alcohol abuse or drug addiction.&#xD;
&#xD;
          -  Administration of a live vaccine within 90 days prior to the first study immunisation&#xD;
             (V4) and throughout the study.&#xD;
&#xD;
          -  Receipt of blood, blood products or plasma derivatives 30 days prior to study entry&#xD;
             (V1).&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Participation in a clinical study within 30 days prior to admission to the study if&#xD;
             investigational or marketed drug were employed. Any disease or condition which in the&#xD;
             Investigator's opinion would exclude the subject from the study.&#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>Sandra Zivotic</last_name>
    <role>Principal Investigator</role>
    <affiliation>CTC-NORTH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ClinicalTrial Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03270800
org study id: 2015-004761-82
nct id: NCT03270800
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate
      the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected
      healthy volunteers.

      The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each
      containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts
      will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to
      one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each
      cohort.

      Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in
      each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the
      DSMB, as soon as the results of the safety and efficacy analyses are available.

      Up to 72 subjects collectively in Phases A & B will be recruited. depending on immunogenicity
      status.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and tolerability of IMX101
time frame: 215 days
description: All subjects who received at least one dose of the IMP will be included in the safety analysis by following parameters:
-Adverse events: AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA). Separate analyses will be conducted using severity, seriousness, and relationship to the IMP. Treatment-emergent adverse events (TEAEs) will be summarised and tabulated according to the primary system organ class and preferred term.
Clinical laboratory and other safety measures Haematology and clinical chemistry will be summarised with descriptive statistics for absolute values und changes from Baseline by visit. Urine dipstick test will be summarised with frequency tables by visit.
Vital signs Vital signs will be summarised with descriptive statistics for absolute values und changes from Baseline by visit.
Local tolerability Injection site assessments will be summarised in frequency tables when the collected data allow for this.
measure: Determination of immune Responses
time frame: 215 days
description: Humoral and cellular immune Response towards IMX101 and detection of inhibitory antibodies
Secondary Endpoint(s):
Detection of vaccine-antigen specific antibodies by Enzyme linked immunosorbent assay (ELISA) at V6, V7, V8 and V9 in the non-infected subjects and at V6, V7, V8, V9, V10 and V11 in the H.pylori infected subjects.
Detection of inhibitory antibodies blocking H.pylori gGT enzymatic activity at V6, V7, V8 and V9 in the non-infected subjects and at V6, V7, V8, V9, V10 and V11 in the H.pylori-infected subjects.
arm group label: IMX101 vaccine as intradermal and sublingual application
arm group type: Experimental
description: IMX101 vaccine will be administered intradermally and sublingually
arm group label: CTA control as intradermal and sublingual application
arm group type: Experimental
description: CTA mucosal adjuvans will be administered intradermally and sublingually
intervention type: Biological
intervention name: CTA control
description: Sublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market.
arm group label: CTA control as intradermal and sublingual application
intervention type: Biological
intervention name: IMX101 vaccine
description: Sublingual and intradermal application of a vaccine, drug product is not yet on the market.
arm group label: IMX101 vaccine as intradermal and sublingual application
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra Zivotic
role: Principal Investigator
affiliation: CTC-NORTH
facility: 
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: Undecided