Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 19 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Tovaxin Autologous T Cell Vaccine
What it measured
Main measures
Evaluation of safety and tolerability
Yearly Intervals
Safety
Other measures (3)
To assess changes in EDSS Scores
Yearly Intervals
Disability progressionTo assess changes in the myelin-reactive profile in the blood
Yearly Intervals
To assess changes in the frequency of MS relapses
Yearly Intervals
Relapses
Who could take part
Relapsing and progressive · 18 to 65 · EDSS 2 to 8
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.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.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.
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History
Started
Jul 2002
Main results due
Jun 2007
Finished
Dec 2008