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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245622

Acronym

TERMS

Enrollment

150

Registered

2005-10-28

Start date

2006-05-31

Completion date

2008-09-30

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Phase 2b Tovaxin, Clinically Isolated Syndrome (CIS), Relapse-Remitting Multiple Sclerosis (RR-MS)

Brief summary

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).

Detailed description

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.

Interventions

BIOLOGICALTovaxin Autologous T cell vaccine

subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24

BIOLOGICALPlacebo

subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS	1 year

Secondary

Measure	Time frame
To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026