Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Tovaxin Autologous T cell vaccine
Placebo
- Placebo
What it measured
Main measures
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
1 year
Safety
Other measures (1)
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
1 year
Blood or spinal fluid markers
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* Aged 18 to 55 years old * Presence of myelin reactive T cells at screening * Diagnosis of CIS with screening MRI that fulfils the Barkhof criteria - dissemination in space * Diagnosis of MS within the past 10 years according to the McDonald criteria (2005) * Baseline EDSS score between 0 and 5.5 inclusively
Exclusion criteria
* Unable to produce T cell vaccine * Disease-modifying treatment for MS during the last 30 days and 60 days for steroidal treatments * Diagnosis of progressive-relapsing, secondary progressive, or primary progressive MS * Planned pregnancy, currently pregnant, or breastfeeding * Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with a clinically isolated syndrome (CIS) and relapse-remitting multiple sclerosis (RR-MS).
Papers
Loading reviews and guidelines…
History
Started
May 2006
Main results due
Sept 2008
Finished
Sept 2008