Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis (DES)

Opexa Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive

Treatments: Biological: Tovaxin Autologous T Cell Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00587691

2000-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable MS disease within 30 days prior to enrollment
• EDSS Score between 2 and 8 inclusively
• Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS.

Exclusion criteria

• Women who are pregnant or breast-feeding or who plan to become pregnant during the study
• Has taken immunomodulating drugs within 60 days prior to screening
• HIV positive

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Dose Level 1

Experimental group

Description:

6-9 million MRTC

Treatment:

Biological: Tovaxin Autologous T Cell Vaccine

Dose Level 2

Experimental group

Description:

30-45 million MRTC

Treatment:

Biological: Tovaxin Autologous T Cell Vaccine

Dose Level 3

Experimental group

Description:

60-90 million MRTC

Treatment:

Biological: Tovaxin Autologous T Cell Vaccine