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Completed

NCT Number: NCT00587691

Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Secondary Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Bellaire Neurology, Bellaire, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tovaxin Autologous T cell vaccine

Biological

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.

Primary outcomes

  1. Evaluation of safety and tolerability

    Time frame: Yearly Intervals

Secondary outcomes

  1. To assess changes in EDSS Scores

    Time frame: Yearly Intervals

  2. To assess changes in the myelin-reactive profile in the blood

    Time frame: Yearly Intervals

  3. To assess changes in the frequency of MS relapses

    Time frame: Yearly Intervals

Sponsors and collaborators

Lead sponsor

Opexa Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: DES

Important dates

Study start
2002
Primary completion
2007
Study completion
2008
First posted
Jan 7, 2008
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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