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

Sponsor
Opexa Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00245622
Collaborator
(none)
150
Enrollment
33
Locations
2
Arms
28.1
Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 1, 2006
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
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

Contacts and Locations

Locations

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

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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00245622
Other Study ID Numbers:
  • 2005-00
First Posted:
Oct 28, 2005
Last Update Posted:
Mar 10, 2014
Last Verified:
Feb 1, 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
Sclerosis

Study Results

No Results Posted as of Mar 10, 2014