Autologous T Cell Vaccine (TCV) for Multiple Sclerosis

Phase 2

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis
• Interventions: Biological: Placebo; Biological: Tovaxin Autologous T cell vaccine

• Registration Number: NCT00245622
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2005-10-20
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-28
• Study Start: 2006-05
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2011-06-27
• Disposition First Submitted QC: 2011-06-27
• Disposition First Posted: 2011-06-28
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2.0 mL subcutaneous injections without autologous myelin reactive T cells
Tovaxin Autologous T cell vaccine	Tovaxin Autologous T cell vaccine	2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS	1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading	1 year

Trial Locations

Locations (33)

Neurological Research Institute; 🇺🇸 Columbus, Ohio, United States

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

St Mary's of Michigan - Field Neuroscience Institute; 🇺🇸 Saginaw, Michigan, United States

Integra Clinical Research, LLC; 🇺🇸 San Antonio, Texas, United States

MidAmerica Neuroscience Institute; 🇺🇸 Lenexa, Kansas, United States

Patricia A Fodor, PC; 🇺🇸 Colorado Springs, Colorado, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Providence St. Vincent Medical Center - Northwest MS Center; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Associates in Neurology; 🇺🇸 Lexington, Kentucky, United States

Lovelace Scientific Resources; 🇺🇸 Sarasota, Florida, United States

Xenoscience - 21st Century Neurology; 🇺🇸 Phoenix, Arizona, United States

Alta Bates Summit Medical Center - East Bay Physicians Medical Group; 🇺🇸 Berkeley, California, United States

Ayres & Associates Clinical Trials; 🇺🇸 Lebanon, New Hampshire, United States

Winthrop University Hospital - Clinical Trials Unit; 🇺🇸 Mineola, New York, United States

North Central Neurology Associates, PC; 🇺🇸 Cullman, Alabama, United States

Bradenton Neurology; 🇺🇸 Bradenton, Florida, United States

Consultants in Neurology, Ltd.; 🇺🇸 Northbrook, Illinois, United States

Medical College of Georgia - Department of Neurology; 🇺🇸 Augusta, Georgia, United States

Neurological Associates; 🇺🇸 Pompano Beach, Florida, United States

Allied Physicians Inc; 🇺🇸 Fort Wayne, Indiana, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

Research Nurse Specialists; 🇺🇸 Lafayette, Louisiana, United States

Upstate Clinical Research, LLC; 🇺🇸 Albany, New York, United States

University Hospital and Medical Center Stony Brook New York; 🇺🇸 Stony Brook, New York, United States

Raleigh Neurology Associates; 🇺🇸 Raleigh, North Carolina, United States

Neurology Consultants of the Carolinas, PA; 🇺🇸 Charlotte, North Carolina, United States

Neurology & Neuroscience Associates, Inc.; 🇺🇸 Akron, Ohio, United States

Neurology Specialists, Inc; 🇺🇸 Dayton, Ohio, United States

The Maxine Mesinger MS Clinic/Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

MS Center at Evergreen; 🇺🇸 Kirkland, Washington, United States

Capitol Neurology; 🇺🇸 Charleston, West Virginia, United States

Central Texas Neurology; 🇺🇸 Round Rock, Texas, United States