Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

Phase 1

Completed

• Conditions: Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Relapsing-Remitting
• Interventions: Biological: Tovaxin Autologous T Cell Vaccine

• Registration Number: NCT00587691
• Lead Sponsor: Opexa Therapeutics, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2007-06
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Study Completion: 2008-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Level 2	Tovaxin Autologous T Cell Vaccine	30-45 million MRTC
Dose Level 1	Tovaxin Autologous T Cell Vaccine	6-9 million MRTC
Dose Level 3	Tovaxin Autologous T Cell Vaccine	60-90 million MRTC

Primary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability	Yearly Intervals

Secondary Outcome Measures

Name	Time	Method
To assess changes in EDSS Scores	Yearly Intervals
To assess changes in the frequency of MS relapses	Yearly Intervals
To assess changes in the myelin-reactive profile in the blood	Yearly Intervals

Trial Locations

Locations (2)

Bellaire Neurology; 🇺🇸 Bellaire, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States