A Study of NeuroVax™, a 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. 200 subjects with Secondary Progressive SPMS

Detailed Description
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Objectives:The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n subjects with secondary progressive MS. Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. Study Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. Subject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score >= 3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects will be randomized equally to NeuroVax™ or I F A ,1 0 0 per arm .

Official Title
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A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

Conditions
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Secondary Progress Multiple Sclerosis, Multiple Sclerosis

Intervention / Treatment
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* Biological: NeuroVax
* Biological: IFA Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 18 and 50 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroVax<br>NeuroVax | Biological: NeuroVax<br>* TCR peptides in IFA<br>|
| Placebo Comparator: IFA Placebo<br>IFA Placebo | Biological: IFA Placebo<br>* IFA Placebo<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 cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS |  | up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. | Secondary MRI measurements | 48 Weeks | 
| Analyses of clinical relapses | Analyses of clinical relapses | 48 Weeks | 
| Measures of neurologic disability EDSS score | Measures of neurologic disability EDSS score | 48 Weeks | 
| Immunologic evaluations | Immunologic evaluations | 48 Weeks | 
| Safety Evaluation | Safety Evaluation | 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