Clinical trial NCT00245622: Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Phase 2b Tovaxin
Clinically Isolated Syndrome (CIS)
Relapse-Remitting Multiple Sclerosis (RR-MS)
Lead sponsor: Opexa Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
timeFrame: 1 year
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, PC
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience - 21st Century Neurology
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center - East Bay Physicians Medical Group
state: California
city: Colorado Springs
country: United States
facility: Patricia A Fodor, PC
state: Colorado
city: Bradenton
country: United States
facility: Bradenton Neurology
state: Florida
city: Pompano Beach
country: United States
facility: Neurological Associates
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia - Department of Neurology
state: Georgia
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd.
state: Illinois
city: Fort Wayne
country: United States
facility: Allied Physicians Inc
state: Indiana
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Lexington
country: United States
facility: Associates in Neurology
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Lafayette
country: United States
facility: Research Nurse Specialists
state: Louisiana
city: Saginaw
country: United States
facility: St Mary's of Michigan - Field Neuroscience Institute
state: Michigan
city: Lebanon
country: United States
facility: Ayres & Associates Clinical Trials
state: New Hampshire
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital - Clinical Trials Unit
state: New York
city: Stony Brook
country: United States
facility: University Hospital and Medical Center Stony Brook New York
state: New York
city: Charlotte
country: United States
facility: Neurology Consultants of the Carolinas, PA
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Akron
country: United States
facility: Neurology & Neuroscience Associates, Inc.
state: Ohio
city: Columbus
country: United States
facility: Neurological Research Institute
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists, Inc
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center - Northwest MS Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: The Maxine Mesinger MS Clinic/Baylor College of Medicine
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research, LLC
state: Texas
city: Kirkland
country: United States
facility: MS Center at Evergreen
state: Washington
city: Charleston
country: United States
facility: Capitol Neurology
state: West Virginia
Study officials:
affiliation: Central Texas Neurology Consultants
name: Edward J Fox, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Opexa Therapeutics, Inc.
name: Jaye Thompson, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Fox 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.