Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
DES
An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2002
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 7, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 11, 2017
January 1, 2017
4.9 years
December 21, 2007
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of safety and tolerability
Yearly Intervals
Secondary Outcomes (3)
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
Study Arms (3)
Dose Level 1
EXPERIMENTAL6-9 million MRTC
Dose Level 2
EXPERIMENTAL30-45 million MRTC
Dose Level 3
EXPERIMENTAL60-90 million MRTC
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bellaire Neurology
Bellaire, Texas, 77401, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (3)
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
PMID: 11642613BACKGROUNDZhang 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.
PMID: 12901569BACKGROUNDZhang 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.
PMID: 11985389BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jaye Thompson, PhD
Opexa Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
July 1, 2002
Primary Completion
June 1, 2007
Study Completion
December 1, 2008
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share