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

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

Detailed Description
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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

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Biological: NeuroVax
* Biological: IFA Incomplete Freund's Adjuvant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroVax<br>NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant | Biological: NeuroVax<br>* NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1<br>* Other names: IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1;|
| Placebo Comparator: IFA Incomplete Freund's Adjuvant<br>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 | Biological: IFA Incomplete Freund's Adjuvant<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Secondary clinical endpoint is the measurement of FOXP3+ expression | Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups | 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. | 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 | 26 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic