NCT00587691

Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Opexa Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.

Conditions

• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Secondary Progressive

Interventions

Type	Name	Description
BIOLOGICAL	Tovaxin Autologous T Cell Vaccine	Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period. Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods. Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods.

Timeline

• Start date: 2002-07-01
• Primary completion: 2007-06-01
• Completion: 2008-12-01
• First posted: 2008-01-07
• Last updated: 2017-01-11

Locations

2 sites across 1 country: United States