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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00245622
First received: October 20, 2005
Last updated: February 6, 2014
Last verified: February 2014

October 20, 2005
February 6, 2014
May 2006
September 2008   (final data collection date for primary outcome measure)
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
Complete list of historical versions of study NCT00245622 on ClinicalTrials.gov Archive Site
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
Not Provided
Not Provided
 
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Biological: Tovaxin Autologous T cell vaccine
    subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
  • Biological: Placebo
    subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
  • Experimental: Tovaxin Autologous T cell vaccine
    2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells
    Intervention: Biological: Tovaxin Autologous T cell vaccine
  • Placebo Comparator: Placebo
    2.0 mL subcutaneous injections without autologous myelin reactive T cells
    Intervention: Biological: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245622
2005-00
Yes
Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc.
Not Provided
Study Chair: Edward J Fox, M.D., Ph.D. Central Texas Neurology Consultants
Study Director: Jaye Thompson, Ph.D. Opexa Therapeutics, Inc.
Opexa Therapeutics, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP