Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
TERMS
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
1 other identifier
interventional
150
1 country
33
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2005
CompletedFirst Posted
Study publicly available on registry
October 28, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMarch 10, 2014
February 1, 2014
2.3 years
October 20, 2005
February 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
1 year
Secondary Outcomes (1)
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
1 year
Study Arms (2)
Tovaxin Autologous T cell vaccine
EXPERIMENTAL2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells
Placebo
PLACEBO COMPARATOR2.0 mL subcutaneous injections without autologous myelin reactive T cells
Interventions
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
North Central Neurology Associates, PC
Cullman, Alabama, 35058, United States
Xenoscience - 21st Century Neurology
Phoenix, Arizona, 85013, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
Berkeley, California, 94705, United States
Patricia A Fodor, PC
Colorado Springs, Colorado, 80919, United States
Bradenton Neurology
Bradenton, Florida, 34205, United States
Neurological Associates
Pompano Beach, Florida, 33060, United States
Lovelace Scientific Resources
Sarasota, Florida, 34233, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
Medical College of Georgia - Department of Neurology
Augusta, Georgia, 30912, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062, United States
Allied Physicians Inc
Fort Wayne, Indiana, 46805, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, 66214, United States
Associates in Neurology
Lexington, Kentucky, 40503, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Research Nurse Specialists
Lafayette, Louisiana, 70503, United States
St Mary's of Michigan - Field Neuroscience Institute
Saginaw, Michigan, 48604, United States
Ayres & Associates Clinical Trials
Lebanon, New Hampshire, 03766, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
Winthrop University Hospital - Clinical Trials Unit
Mineola, New York, 11501, United States
University Hospital and Medical Center Stony Brook New York
Stony Brook, New York, 11794-8121, United States
Neurology Consultants of the Carolinas, PA
Charlotte, North Carolina, 28204, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, 44302, United States
Neurological Research Institute
Columbus, Ohio, 43221, United States
Neurology Specialists, Inc
Dayton, Ohio, 45408, United States
Providence St. Vincent Medical Center - Northwest MS Center
Portland, Oregon, 97225, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Maxine Mesinger MS Clinic/Baylor College of Medicine
Houston, Texas, 77030, United States
Central Texas Neurology
Round Rock, Texas, 78681, United States
Integra Clinical Research, LLC
San Antonio, Texas, 78229, United States
MS Center at Evergreen
Kirkland, Washington, 98101, United States
Capitol Neurology
Charleston, West Virginia, 25301, United States
Related Publications (2)
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.
RESULTFox E, Wynn D, Cohan S, Rill D, McGuire D, Markowitz C. A randomized clinical trial of autologous T-cell therapy in multiple sclerosis: subset analysis and implications for trial design. Mult Scler. 2012 Jun;18(6):843-52. doi: 10.1177/1352458511428462. Epub 2011 Nov 6.
PMID: 22065170DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Edward J Fox, M.D., Ph.D.
Central Texas Neurology Consultants
- STUDY DIRECTOR
Jaye Thompson, Ph.D.
Opexa Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2005
First Posted
October 28, 2005
Study Start
May 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
March 10, 2014
Record last verified: 2014-02