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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | 6-9 million MRTC |
|
| Dose Level 2 | Experimental | 30-45 million MRTC |
|
| Dose Level 3 | Experimental | 60-90 million MRTC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tovaxin Autologous T Cell Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety and tolerability | Yearly Intervals |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaye Thompson, PhD | Opexa Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellaire Neurology | Bellaire | Texas | 77401 | United States | ||
| Baylor College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11642613 | Background | Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55. | |
| 12901569 | Background | 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. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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|
| Yearly Intervals |
| Houston |
| Texas |
| 77030 |
| United States |
| 11985389 | Background | 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. |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |