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

Overview

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

Full Title of Study: “A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 9, 2024

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

Interventions

  • Biological: NeuroVax
    • NeuroVax consists of a Trivalent 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Immune Response BioPharma, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard M Bartholomew, Ph.D, Study Director, Immune Response BioPharma, Inc.
  • Overall Contact(s)
    • Richard M Bartholomew, Ph.D, 1-858-414-4664, Richardmbartholomew@gmail.com

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