A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
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
CRO
San Diego, California, United States
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
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
Time frame: 26 Weeks
A Secondary clinical endpoint is the measurement of FOXP3+ expression
Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
Time frame: 26 Weeks
A Secondary clinical endpoint is the measurment of EDSS scores
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.
Time frame: 26 Weeks
A Secondary clinical endpoint is the measurement of clinical relapses
To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26
Time frame: 26 Weeks
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