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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245622
First Posted: October 28, 2005
Last Update Posted: March 10, 2014
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.
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
  Purpose
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 Intervention Phase
Relapsing-Remitting Multiple Sclerosis Biological: Tovaxin Autologous T cell vaccine Biological: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Opexa Therapeutics, Inc.:

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

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

Enrollment: 150
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00245622


  Show 33 Study Locations
Sponsors and Collaborators
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.
  More Information

Additional Information:
Publications:
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00245622     History of Changes
Other Study ID Numbers: 2005-00
First Submitted: October 20, 2005
First Posted: October 28, 2005
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:
Sclerosis
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs