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A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02200718
Recruitment Status : Not yet recruiting
First Posted : July 25, 2014
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Immune Response BioPharma, Inc.

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE July 25, 2014
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE November 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups [ Time Frame: 26 Weeks ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02200718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • A Secondary clinical endpoint is the measurement of FOXP3+ expression [ Time Frame: 26 Weeks ]
    Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
  • A Secondary clinical endpoint is the measurment of EDSS scores [ Time Frame: 26 Weeks ]
    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.
  • A Secondary clinical endpoint is the measurement of clinical relapses [ Time Frame: 26 Weeks ]
    To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Official Title  ICMJE A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Brief Summary A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Biological: NeuroVax
    NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
    Other Name: IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
  • Biological: IFA Incomplete Freund's Adjuvant
    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
Study Arms  ICMJE
  • Experimental: NeuroVax
    NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant
    Intervention: Biological: NeuroVax
  • Placebo Comparator: IFA Incomplete Freund's Adjuvant
    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: Biological: IFA Incomplete Freund's Adjuvant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages Eligible for Study: 5 Years to 17 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No Criteria
  • Subject is between 5 and 17 years of age, inclusive
  • Clinically diagnosed Pediatric MS
  • Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course
  • Expanded Disability Status Scale (EDSS) <= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening
  • Laboratory values within the following limits:

    • Creatinine 1 . 5 x high normal
    • Hemoglobin

Exclusion Criteria:

  • Subjects currently prescribed Campath or Lemtrada
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Richard M Bartholomew, Ph.D 1-858-414-4664 Richardmbartholomew@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02200718
Other Study ID Numbers  ICMJE IR902-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immune Response BioPharma, Inc.
Study Sponsor  ICMJE Immune Response BioPharma, Inc.
Collaborators  ICMJE Oregon Health and Science University
Investigators  ICMJE
Study Chair: Dennis Bourdette, FAAN MD Oregon Health and Science University
Study Director: Richard M Bartholomew, Ph.D Immune Response BioPharma, Inc.
PRS Account Immune Response BioPharma, Inc.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP