Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.

Detailed Description
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The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.

Official Title
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An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive

Intervention / Treatment
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* Biological: Tovaxin Autologous T Cell Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable MS disease within 30 days prior to enrollment EDSS Score between 2 and 8 inclusively Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS. Exclusion Criteria: Women who are pregnant or breast-feeding or who plan to become pregnant during the study Has taken immunomodulating drugs within 60 days prior to screening HIV positive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Level 1<br>6-9 million MRTC | Biological: Tovaxin Autologous T Cell Vaccine<br>* Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period. Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods. Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods.<br>|
| Experimental: Dose Level 2<br>30-45 million MRTC | Biological: Tovaxin Autologous T Cell Vaccine<br>* Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period. Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods. Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods.<br>|
| Experimental: Dose Level 3<br>60-90 million MRTC | Biological: Tovaxin Autologous T Cell Vaccine<br>* Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period. Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods. Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety and tolerability |  | Yearly Intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes in EDSS Scores |  | Yearly Intervals | 
| To assess changes in the myelin-reactive profile in the blood |  | Yearly Intervals | 
| To assess changes in the frequency of MS relapses |  | Yearly Intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tovaxin, TCV, Autologous