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 I Phase II

MedlinePlus related topics:

Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

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
Estimated Study Completion Date:	June 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dose Level 1: Experimental 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.
Dose Level 2: Experimental 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.
Dose Level 3: Experimental 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
	Baylor College of Medicine
	Houston, Texas, United States, 77030
	Bellaire Neurology
	Bellaire, Texas, United States, 77401

Sponsors and Collaborators

Opexa Therapeutics, Inc.

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:	Opexa Therapeutics, Inc. ( Jim Williams, Ph.D., COO & VP of Regulatory Affairs )
Study ID Numbers:	2000-03
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00587691
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Opexa Therapeutics, Inc.:

Tovaxin

TCV

Autologous

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Neoplasm Metastasis

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Autoimmune Diseases of the Nervous System

Multiple Sclerosis, Chronic Progressive

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Opexa Therapeutics, Inc.
Information provided by:	Opexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00587691