Autologous T Cell Vaccine (TCV) for Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— TERMS  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245622
• Other study ID #: 2005-00
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2005
• Last updated: February 6, 2014
• Start date: May 2006
• Est. completion date: September 2008

Study information

• Verified date: February 2014
• Source: Opexa Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• Tovaxin Autologous T cell vaccine
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
• Placebo
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24

Locations

Country	Name	City	State
United States	Neurology & Neuroscience Associates, Inc.	Akron	Ohio
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Shepherd Center	Atlanta	Georgia
United States	Medical College of Georgia - Department of Neurology	Augusta	Georgia
United States	Alta Bates Summit Medical Center - East Bay Physicians Medical Group	Berkeley	California
United States	Bradenton Neurology	Bradenton	Florida
United States	Capitol Neurology	Charleston	West Virginia
United States	Neurology Consultants of the Carolinas, PA	Charlotte	North Carolina
United States	Patricia A Fodor, PC	Colorado Springs	Colorado
United States	Neurological Research Institute	Columbus	Ohio
United States	North Central Neurology Associates, PC	Cullman	Alabama
United States	Neurology Specialists, Inc	Dayton	Ohio
United States	Allied Physicians Inc	Fort Wayne	Indiana
United States	The Maxine Mesinger MS Clinic/Baylor College of Medicine	Houston	Texas
United States	MS Center at Evergreen	Kirkland	Washington
United States	Research Nurse Specialists	Lafayette	Louisiana
United States	Ayres & Associates Clinical Trials	Lebanon	New Hampshire
United States	MidAmerica Neuroscience Institute	Lenexa	Kansas
United States	Associates in Neurology	Lexington	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Winthrop University Hospital - Clinical Trials Unit	Mineola	New York
United States	Consultants in Neurology, Ltd.	Northbrook	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	HOPE Research Institute	Phoenix	Arizona
United States	Xenoscience - 21st Century Neurology	Phoenix	Arizona
United States	Neurological Associates	Pompano Beach	Florida
United States	Providence St. Vincent Medical Center - Northwest MS Center	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Central Texas Neurology	Round Rock	Texas
United States	St Mary's of Michigan - Field Neuroscience Institute	Saginaw	Michigan
United States	Integra Clinical Research, LLC	San Antonio	Texas
United States	Lovelace Scientific Resources	Sarasota	Florida
United States	University Hospital and Medical Center Stony Brook New York	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Opexa Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS		1 year	Yes
Secondary	To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading		1 year	No

External Links

•   Sponsor's website