<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/NCT02200718</url>
  </required_header>
  <id_info>
    <org_study_id>IR902-007</org_study_id>
    <nct_id>NCT02200718</nct_id>
  </id_info>
  <brief_title>A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis</brief_title>
  <official_title>A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immune Response BioPharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immune Response BioPharma, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple&#xD;
      Sclerosis to demonstrate safety &amp; efficacy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Multi-Center Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for&#xD;
      Pediatric Multiple Sclerosis to demonstrate safety &amp; efficacy 12 subjects with pediatric MS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 31, 2020</start_date>
  <completion_date type="Anticipated">November 9, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 9, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary clinical endpoints are comparisons of MRI &amp; WBC measurements between the treatment groups</measure>
    <time_frame>26 Weeks</time_frame>
    <description>The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI &amp; to compare the increases of WBC white blood cell counts in subjects in the treatment groups with Pediatric MS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A Secondary clinical endpoint is the measurement of FOXP3+ expression</measure>
    <time_frame>26 Weeks</time_frame>
    <description>Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A Secondary clinical endpoint is the measurment of EDSS scores</measure>
    <time_frame>26 Weeks</time_frame>
    <description>To compare between treatment groups the Measures of neurologic disability EDSS scores utilizing the Kurtzke scale, Patients will be assessed using the EDSS, a 25-foot timed walk, and a nine-hole peg test assessments at weeks 0, 4, 8, 12, 16, 20 &amp; 26 visit then exit the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A Secondary clinical endpoint is the measurement of clinical relapses</measure>
    <time_frame>26 Weeks</time_frame>
    <description>To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>NeuroVax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IFA Incomplete Freund's Adjuvant</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil a surfactant system designed to make a water-in-oil emulsion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NeuroVax</intervention_name>
    <description>NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1</description>
    <arm_group_label>NeuroVax</arm_group_label>
    <other_name>IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IFA Incomplete Freund's Adjuvant</intervention_name>
    <description>IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil and a surfactant system designed to make a water-in-oil emulsion</description>
    <arm_group_label>IFA Incomplete Freund's Adjuvant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages Eligible for Study: 5 Years to 17 Years&#xD;
&#xD;
          -  Genders Eligible for Study: Both&#xD;
&#xD;
          -  Accepts Healthy Volunteers: No Criteria&#xD;
&#xD;
          -  Subject is between 5 and 17 years of age, inclusive&#xD;
&#xD;
          -  Clinically diagnosed Pediatric MS&#xD;
&#xD;
          -  Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a&#xD;
             pediatric MS course&#xD;
&#xD;
          -  Expanded Disability Status Scale (EDSS) &lt;= score 6.5 (Appendix B) Two or more&#xD;
             documented clinical relapses of MS in the preceding 24 months OR one documented&#xD;
             clinical relapse of MS in the preceding 12 months prior to screening&#xD;
&#xD;
          -  Laboratory values within the following limits:&#xD;
&#xD;
               -  Creatinine 1 . 5 x high normal&#xD;
&#xD;
               -  Hemoglobin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects currently prescribed Campath or Lemtrada&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard M Bartholomew, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Immune Response BioPharma, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard M Bartholomew, Ph.D</last_name>
    <phone>1-858-414-4664</phone>
    <email>Richardmbartholomew@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CRO</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92129</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Richard M Bartholomew, PhD</last_name>
      <phone>858-414-4664</phone>
      <email>Richardmbartholomew@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.immuneresponse.net</url>
    <description>Immune Response BioPharma, Inc.</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Freund's Adjuvant</mesh_term>
  </intervention_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/NCT02200718
org study id: IR902-007
nct id: NCT02200718
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple
      Sclerosis to demonstrate safety & efficacy
A Multi-Center Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for
      Pediatric Multiple Sclerosis to demonstrate safety & efficacy 12 subjects with pediatric MS
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
time frame: 26 Weeks
description: The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI & to compare the increases of WBC white blood cell counts in subjects in the treatment groups with Pediatric MS
measure: A Secondary clinical endpoint is the measurement of FOXP3+ expression
time frame: 26 Weeks
description: Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
measure: A Secondary clinical endpoint is the measurment of EDSS scores
time frame: 26 Weeks
description: To compare between treatment groups the Measures of neurologic disability EDSS scores utilizing the Kurtzke scale, Patients will be assessed using the EDSS, a 25-foot timed walk, and a nine-hole peg test assessments at weeks 0, 4, 8, 12, 16, 20 & 26 visit then exit the study.
measure: A Secondary clinical endpoint is the measurement of clinical relapses
time frame: 26 Weeks
description: To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26
arm group label: NeuroVax
arm group type: Experimental
description: NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant
arm group label: IFA Incomplete Freund's Adjuvant
arm group type: Placebo Comparator
description: IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil a surfactant system designed to make a water-in-oil emulsion
intervention type: Biological
intervention name: NeuroVax
description: NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
arm group label: NeuroVax
other name: IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
intervention type: Biological
intervention name: IFA Incomplete Freund's Adjuvant
description: IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil and a surfactant system designed to make a water-in-oil emulsion
arm group label: IFA Incomplete Freund's Adjuvant
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: Richard M Bartholomew, Ph.D
role: Study Director
affiliation: Immune Response BioPharma, Inc.
last name: Richard M Bartholomew, Ph.D
phone: 1-858-414-4664
email: Richardmbartholomew@gmail.com
facility: 
contact: 
country: United States
url: http://www.immuneresponse.net
description: Immune Response BioPharma, Inc.
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Freund's Adjuvant