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

Study Overview
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Brief Summary
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Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary Progressive SPMS.

Detailed Description
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The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

Official Title
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A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination

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: 18 Years to 70 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Subject is between 18 and 70 years of age, inclusive. Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course. Expanded Disability Status Scale (EDSS) >=score 3.5 (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 1 2 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: 18 Years
Maximum Age: 70 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 | Biological: NeuroVax<br>* NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA<br>|
| Placebo Comparator: IFA Incomplete Freund's Adjuvant<br>Incomplete Freund's Adjuvant IFA | Biological: IFA Incomplete Freund's Adjuvant<br>* IFA Placebo Incomplete Freund's Adjuvant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score | The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements | 48 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary measurements objectives immunologic evaluations | Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases | 48 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax