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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tovaxin Autologous T cell vaccine
Placebo
Sponsored by
Opexa Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Phase 2b Tovaxin, Clinically Isolated Syndrome (CIS), Relapse-Remitting Multiple Sclerosis (RR-MS)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Central Neurology Associates, PC
  • Xenoscience - 21st Century Neurology
  • HOPE Research Institute
  • Alta Bates Summit Medical Center - East Bay Physicians Medical Group
  • Patricia A Fodor, PC
  • Bradenton Neurology
  • Neurological Associates
  • Lovelace Scientific Resources
  • Shepherd Center
  • Medical College of Georgia - Department of Neurology
  • Consultants in Neurology, Ltd.
  • Allied Physicians Inc
  • MidAmerica Neuroscience Institute
  • Associates in Neurology
  • University of Louisville Hospital
  • Research Nurse Specialists
  • St Mary's of Michigan - Field Neuroscience Institute
  • Ayres & Associates Clinical Trials
  • Upstate Clinical Research, LLC
  • Winthrop University Hospital - Clinical Trials Unit
  • University Hospital and Medical Center Stony Brook New York
  • Neurology Consultants of the Carolinas, PA
  • Raleigh Neurology Associates
  • Neurology & Neuroscience Associates, Inc.
  • Neurological Research Institute
  • Neurology Specialists, Inc
  • Providence St. Vincent Medical Center - Northwest MS Center
  • University of Pennsylvania
  • The Maxine Mesinger MS Clinic/Baylor College of Medicine
  • Central Texas Neurology
  • Integra Clinical Research, LLC
  • MS Center at Evergreen
  • Capitol Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tovaxin Autologous T cell vaccine

Placebo

Arm Description

2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells

2.0 mL subcutaneous injections without autologous myelin reactive T cells

Outcomes

Primary Outcome Measures

To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS

Secondary Outcome Measures

To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading

Full Information

First Posted
October 20, 2005
Last Updated
February 6, 2014
Sponsor
Opexa Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00245622
Brief Title
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
Acronym
TERMS
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Opexa Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
Phase 2b Tovaxin, Clinically Isolated Syndrome (CIS), Relapse-Remitting Multiple Sclerosis (RR-MS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tovaxin Autologous T cell vaccine
Arm Type
Experimental
Arm Description
2.0 mL subcutaneous formulated with 30-45 million autologous myelin reactive T cells
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2.0 mL subcutaneous injections without autologous myelin reactive T cells
Intervention Type
Biological
Intervention Name(s)
Tovaxin Autologous T cell vaccine
Intervention Description
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
Primary Outcome Measure Information:
Title
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward J Fox, M.D., Ph.D.
Organizational Affiliation
Central Texas Neurology Consultants
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jaye Thompson, Ph.D.
Organizational Affiliation
Opexa Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
North Central Neurology Associates, PC
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Xenoscience - 21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Alta Bates Summit Medical Center - East Bay Physicians Medical Group
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Patricia A Fodor, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States
Facility Name
Bradenton Neurology
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Neurological Associates
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Lovelace Scientific Resources
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Medical College of Georgia - Department of Neurology
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Consultants in Neurology, Ltd.
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Allied Physicians Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Associates in Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Nurse Specialists
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
St Mary's of Michigan - Field Neuroscience Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Ayres & Associates Clinical Trials
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Winthrop University Hospital - Clinical Trials Unit
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
University Hospital and Medical Center Stony Brook New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States
Facility Name
Neurology Consultants of the Carolinas, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neurology & Neuroscience Associates, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Neurological Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Neurology Specialists, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Providence St. Vincent Medical Center - Northwest MS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Maxine Mesinger MS Clinic/Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Neurology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Integra Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
MS Center at Evergreen
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Capitol Neurology
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
PubMed Identifier
22065170
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.
Results Reference
derived
Links:
URL
http://www.opexatherapeutics.com
Description
Sponsor's website

Learn more about this trial

Autologous T Cell Vaccine (TCV) for Multiple Sclerosis

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