Trial | NCT00587691  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tovaxin ...

  • Study Participants

    16
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.
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.
Study Started
Jul 31
2002
Primary Completion
Jun 30
2007
Study Completion
Dec 31
2008
Last Update
Jan 11
2017
Estimate

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.

Dose Level 1 Experimental

6-9 million MRTC

Dose Level 2 Experimental

30-45 million MRTC

Dose Level 3 Experimental

60-90 million MRTC

Criteria 

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
No Results Posted