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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary: 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
Sponsor: Immune Response BioPharma, Inc.

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Immune Response BioPharma, Inc.

Dates:
Date Received: July 17, 2014
Date Started: November 2017
Date Completion: November 2019
Last Updated: February 22, 2016
Last Verified: February 2016