NCT00245622

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Opexa Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Tovaxin Autologous T cell vaccine	subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24
BIOLOGICAL	Placebo	subcutaneous injections administered by healthcare provider at weeks 0, 4, 8, 12, and 24

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-10-28
• Last updated: 2014-03-10

Locations

33 sites across 1 country: United States