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Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis (DES)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tovaxin Autologous T Cell Vaccine
Sponsored by
Opexa Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Tovaxin, TCV, Autologous

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable MS disease within 30 days prior to enrollment
  • EDSS Score between 2 and 8 inclusively
  • Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding or who plan to become pregnant during the study
  • Has taken immunomodulating drugs within 60 days prior to screening
  • HIV positive

Sites / Locations

  • Bellaire Neurology
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Level 1

Dose Level 2

Dose Level 3

Arm Description

6-9 million MRTC

30-45 million MRTC

60-90 million MRTC

Outcomes

Primary Outcome Measures

Evaluation of safety and tolerability

Secondary Outcome Measures

To assess changes in EDSS Scores
To assess changes in the myelin-reactive profile in the blood
To assess changes in the frequency of MS relapses

Full Information

First Posted
December 21, 2007
Last Updated
January 9, 2017
Sponsor
Opexa Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00587691
Brief Title
Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
Acronym
DES
Official Title
An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 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
The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.
Detailed Description
The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
Keywords
Tovaxin, TCV, Autologous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
6-9 million MRTC
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
30-45 million MRTC
Arm Title
Dose Level 3
Arm Type
Experimental
Arm Description
60-90 million MRTC
Intervention Type
Biological
Intervention Name(s)
Tovaxin Autologous T Cell Vaccine
Intervention Description
Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period. Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods. Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods.
Primary Outcome Measure Information:
Title
Evaluation of safety and tolerability
Time Frame
Yearly Intervals
Secondary Outcome Measure Information:
Title
To assess changes in EDSS Scores
Time Frame
Yearly Intervals
Title
To assess changes in the myelin-reactive profile in the blood
Time Frame
Yearly Intervals
Title
To assess changes in the frequency of MS relapses
Time Frame
Yearly Intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable MS disease within 30 days prior to enrollment EDSS Score between 2 and 8 inclusively Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS. Exclusion Criteria: Women who are pregnant or breast-feeding or who plan to become pregnant during the study Has taken immunomodulating drugs within 60 days prior to screening HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaye Thompson, PhD
Organizational Affiliation
Opexa Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Bellaire Neurology
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11642613
Citation
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
Results Reference
background
PubMed Identifier
12901569
Citation
Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
Results Reference
background
PubMed Identifier
11985389
Citation
Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.
Results Reference
background

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Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

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