Autologous T Cell Vaccine (TCV) for Multiple Sclerosis (TERMS)

February 6, 2014 updated by: Opexa Therapeutics, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS

This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • North Central Neurology Associates, PC
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Hope Research Institute
      • Phoenix, Arizona, United States, 85013
        • Xenoscience - 21st Century Neurology
    • California
      • Berkeley, California, United States, 94705
        • Alta Bates Summit Medical Center - East Bay Physicians Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80919
        • Patricia A Fodor, PC
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Neurology
      • Pompano Beach, Florida, United States, 33060
        • Neurological Associates
      • Sarasota, Florida, United States, 34233
        • Lovelace Scientific Resources
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia - Department of Neurology
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology, Ltd.
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Allied Physicians Inc
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • MidAmerica Neuroscience Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Associates in Neurology
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Research Nurse Specialists
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • St Mary's of Michigan - Field Neuroscience Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Ayres & Associates Clinical Trials
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research, LLC
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital - Clinical Trials Unit
      • Stony Brook, New York, United States, 11794-8121
        • University Hospital and Medical Center Stony Brook New York
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Neurology Consultants of the Carolinas, PA
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
    • Ohio
      • Akron, Ohio, United States, 44302
        • Neurology & Neuroscience Associates, Inc.
      • Columbus, Ohio, United States, 43221
        • Neurological Research Institute
      • Dayton, Ohio, United States, 45408
        • Neurology Specialists, Inc
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center - Northwest MS Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • The Maxine Mesinger MS Clinic/Baylor College of Medicine
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology
      • San Antonio, Texas, United States, 78229
        • Integra Clinical Research, Llc
    • Washington
      • Kirkland, Washington, United States, 98101
        • MS Center at Evergreen
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Capitol Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 55 years old
  • Presence of myelin reactive T cells at screening
  • Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space
  • Diagnosis of MS within the past 10 years according to the McDonald criteria (2005)
  • Baseline EDSS score between 0 and 5.5 inclusively

Exclusion Criteria:

  • Unable to produce T cell vaccine
  • Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments
  • Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS
  • Planned pregnancy, currently pregnant, or breastfeeding
  • Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tovaxin Autologous T cell vaccine
2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells
Biological: Tovaxin Autologous T cell vaccine
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
Placebo Comparator: Placebo
2.0 mL subcutaneous injections without autologous myelin reactive T cells
Biological: Placebo
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Opexa Therapeutics, Inc.

Investigators

  • Study Chair: Edward J Fox, M.D., Ph.D., Central Texas Neurology Consultants
  • Study Director: Jaye Thompson, Ph.D., Opexa Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 20, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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