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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245622
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : March 10, 2014
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Biological: Tovaxin Autologous T cell vaccine Biological: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
Study Start Date : May 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245622

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

Additional Information:
Publications of Results:
Fox E, Markowitz C, Cohan S, Wynn D. TERMS Trial TCV Secondary Analysis of Clinical and Immunological Outcoms in Patients with Relapsing Remitting MS. Poster presentation P06.132 at the 61st Annual Meeting of the American Academy of Neurology (AAN) on 01 May 2009.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Opexa Therapeutics, Inc. Identifier: NCT00245622     History of Changes
Other Study ID Numbers: 2005-00
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: February 2014

Keywords provided by Opexa Therapeutics, Inc.:
Phase 2b Tovaxin
Clinically Isolated Syndrome (CIS)
Relapse-Remitting Multiple Sclerosis (RR-MS)

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs