Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis (DES)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive
• Intervention / Treatment: Biological: Tovaxin Autologous T Cell Vaccine

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Neurology
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level 1; 6-9 million MRTC	Biological: Tovaxin Autologous T Cell Vaccine; 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.
Experimental: Dose Level 2; 30-45 million MRTC	Biological: Tovaxin Autologous T Cell Vaccine; 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.
Experimental: Dose Level 3; 60-90 million MRTC	Biological: Tovaxin Autologous T Cell Vaccine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of safety and tolerability	Yearly Intervals

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Opexa Therapeutics, Inc.
• Investigators: Study Director: Jaye Thompson, PhD, Opexa Therapeutics

Publications and helpful links

General Publications

• Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
• Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
• Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Autologous; Tovaxin; TCV
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 2000-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No