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

Phase 1

Not yet recruiting

• Conditions: Multiple Sclerosis
• Interventions: Biological: NeuroVax; Biological: IFA Incomplete Freund's Adjuvant

• Registration Number: NCT02200718
• Lead Sponsor: Immune Response BioPharma, Inc.

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 Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31
• Study Start: 2020-12-31
• Primary Completion: 2024-11-09
• Study Completion: 2024-11-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NeuroVax	NeuroVax	NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant
IFA Incomplete Freund's Adjuvant	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

CRO; 🇺🇸 San Diego, California, United States