Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
Autologous T Cell Vaccine (TCV) for Multiple Sclerosis
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).
A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS.
 Subjects who provide written, informed consent will complete screening and procurement
 assessments and provide blood to be used for vaccine production. Eligible subjects will be
 enrolled to receive either Tovaxin or placebo and will complete baseline assessments.
 Randomization and enrolled subjects will receive study treatment by subcutaneous injections
 at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries,
 urinalysis, Expanded Disability Status Scale (EDSS), MSFC, MSQLI, magnetic resonance imaging
 (MRI), and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.
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