Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— DES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587691
• Other study ID #: 2000-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 21, 2007
• Last updated: January 9, 2017
• Start date: July 2002
• Est. completion date: December 2008

Study information

• Verified date: January 2017
• Source: Opexa Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Bellaire Neurology	Bellaire	Texas
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Opexa Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety and tolerability		Yearly Intervals	Yes
Secondary	To assess changes in EDSS Scores		Yearly Intervals	Yes
Secondary	To assess changes in the myelin-reactive profile in the blood		Yearly Intervals	No
Secondary	To assess changes in the frequency of MS relapses		Yearly Intervals	Yes