Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive	Biological: Tovaxin Autologous T Cell Vaccine	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Opexa Therapeutics, Inc.:

Primary Outcome Measures:

Evaluation of safety and tolerability [ Time Frame: Yearly Intervals ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess changes in EDSS Scores [ Time Frame: Yearly Intervals ] [ Designated as safety issue: Yes ]
To assess changes in the myelin-reactive profile in the blood [ Time Frame: Yearly Intervals ] [ Designated as safety issue: No ]
To assess changes in the frequency of MS relapses [ Time Frame: Yearly Intervals ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	July 2002
Study Completion Date:	December 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dose Level 1 6-9 million MRTC	Biological: Tovaxin Autologous T Cell Vaccine 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.
Experimental: Dose Level 2 30-45 million MRTC	Biological: Tovaxin Autologous T Cell Vaccine 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.
Experimental: Dose Level 3 60-90 million MRTC	Biological: Tovaxin Autologous T Cell Vaccine 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587691

Locations

United States, Texas
Bellaire Neurology
Bellaire, Texas, United States, 77401
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Opexa Therapeutics, Inc.

Investigators

Study Director:

Jaye Thompson, PhD

Opexa Therapeutics

More Information

Publications:

Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55. Review.

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. Review.

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.

Responsible Party:	Jaye Thompson, PhD, Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00587691 History of Changes
Other Study ID Numbers:	2000-03
Study First Received:	December 21, 2007
Last Updated:	June 27, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Opexa Therapeutics, Inc.:

Tovaxin
TCV
Autologous

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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