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

Sponsor
Immune Response BioPharma, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT02200718
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
46.3
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy

Condition or Disease Intervention/Treatment Phase
  • Biological: NeuroVax
  • Biological: IFA Incomplete Freund's Adjuvant
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Anticipated Study Start Date :
Dec 31, 2020
Anticipated Primary Completion Date :
Nov 9, 2024
Anticipated Study Completion Date :
Nov 9, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Biological: NeuroVax
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
Other Names:
  • IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1

    		•
    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

    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

    Outcome Measures

    Primary Outcome Measures

    1. The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups [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

    Secondary Outcome Measures

    1. A Secondary clinical endpoint is the measurement of FOXP3+ expression [26 Weeks]

      Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups

    2. A Secondary clinical endpoint is the measurment of EDSS scores [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.

    3. A Secondary clinical endpoint is the measurement of clinical relapses [26 Weeks]

      To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CRO San Diego California United States 92129

    Sponsors and Collaborators

    • Immune Response BioPharma, Inc.

    Investigators

    • Study Director: Richard M Bartholomew, Ph.D, Immune Response BioPharma, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Immune Response BioPharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT02200718
    Other Study ID Numbers:
    • IR902-007
    First Posted:
    Jul 25, 2014
    Last Update Posted:
    Mar 31, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Immune Response BioPharma, Inc.
    Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Freund's Adjuvant

    Study Results

    No Results Posted as of Mar 31, 2020