Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
NCT ID: NCT00587691
Last Updated: 2017-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2002-07-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Level 1
6-9 million MRTC
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
30-45 million MRTC
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
60-90 million MRTC
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Has taken immunomodulating drugs within 60 days prior to screening
* HIV positive
18 Years
65 Years
ALL
No
Sponsors
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Opexa Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jaye Thompson, PhD
Role: STUDY_DIRECTOR
Opexa Therapeutics
Locations
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Bellaire Neurology
Bellaire, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
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.
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.
Other Identifiers
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2000-03
Identifier Type: -
Identifier Source: org_study_id
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