DES: Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Evaluation of safety and tolerability [Yearly Intervals]
Secondary Outcome Measures
- To assess changes in EDSS Scores [Yearly Intervals]
- To assess changes in the myelin-reactive profile in the blood [Yearly Intervals]
- To assess changes in the frequency of MS relapses [Yearly Intervals]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bellaire Neurology | Bellaire | Texas | United States | 77401 |
| 2 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Opexa Therapeutics, Inc.
Investigators
- Study Director: Jaye Thompson, PhD, Opexa Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
- 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 J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55. 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.
- 2000-03