Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic
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
Interventions
BIOLOGICALNeuroVax
NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
BIOLOGICALIFA 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
Sponsors
Immune Response BioPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactRichard M Bartholomew, Ph.D
Outcome results
None listed