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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00587691

Acronym

DES

Enrollment

Registered

2008-01-07

Start date

2002-07-31

Completion date

2008-12-31

Last updated

2017-01-11

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

Conditions

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

Keywords

Tovaxin, TCV, Autologous

Brief 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.

Interventions

BIOLOGICALTovaxin 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Evaluation of safety and tolerability	Yearly Intervals

Secondary

Measure	Time frame
To assess changes in EDSS Scores	Yearly Intervals
To assess changes in the myelin-reactive profile in the blood	Yearly Intervals
To assess changes in the frequency of MS relapses	Yearly Intervals

Countries

United States

Outcome results

None listed

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