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TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00228228
First Posted: September 28, 2005
Last Update Posted: August 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

In the present study, we, the investigators at Sheba Medical Center, intend to evaluate T cell vaccination (TCV) in patients with probable multiple sclerosis (MS) within up to 3 months after the first clinical attack. It is of the utmost importance to evaluate the treatment effects at the onset of disease, i.e. in patients with probable MS, in order to evaluate whether early treatment can prevent the second attack (conversion to definite MS). Moreover, at disease onset, the immunological process of epitope spreading associated with the exposure of the immune system to myelin antigens is still limited. With additional attacks, increased recognition of new self-determinants of encephalitogenic peptides presented to the immune system during the inflammatory process occurs, and enhances further disease activity. The aim of the early TCV treatment approach is to stop this process as early as possible, during the onset of the disease, thus preventing additional attacks and disease progression.

We will evaluate the effect of TCV on clinical, immunological and magnetic resonance imaging (MRI) parameters in patients with probable MS.


Condition Intervention Phase
Multiple Sclerosis Biological: T cell vaccination Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The rate of progression to definite MS (second attack) during the study
  • Time to progression to definite MS (second attack)

Secondary Outcome Measures:
  • Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final (F) MRIs
  • Change in total volume of new GD enhancing lesions from two baseline MRIs (B) to the final MRIs (F)
  • The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS)

Estimated Enrollment: 80
Study Start Date: May 2002
Estimated Study Completion Date: December 2006
Detailed Description:

Inclusion criteria:

  • Age: 15 - 50 years.
  • Three months within the acute onset of neurological symptoms suggestive of the first attack of multiple sclerosis.
  • Diagnosis of CPMS C3 (Poser criteria).
  • Positive brain MRI according to Fazekas criteria.
  • Negative pregnancy test and use of effective contraceptive for female patients who are sexually active.
  • Signed written informed consent.

Exclusion criteria:

  • Blood tests suggestive of other autoimmune diseases.
  • Known allergic reactions to MRI contrast media.
  • A clear regression of the neurological symptoms after the first attack that suggests a primary-progressive course.
  • Corticosteroid treatment in the previous 4 weeks (28 days).
  • Previous treatment with immunosuppressive medications such as cyclophosphamide, azathioprine, methotrexate, mitoxantrone or cyclosporine.
  • Previous treatment with interferon beta 1a or 1b, copolymer-1, IVIg, plasmapheresis.
  Eligibility

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 15-50
  • Three months within the acute onset of neurological symptoms suggestive of multiple sclerosis
  • Diagnosis of clinically probable MS (CPMS) C3: 1 attack with at least 1 clinical manifestation in addition to positive brain MRI as defined in the protocol, signifying paraclinical evidence (Poser criteria 1983).
  • Positive Brain MRI: at least 4 focal lesions involving the white matter of 3 lesions if one is periventricular > 3mm diameter, each
  • Negative pregnancy test and use of effective contraceptives for female patients who are sexually active.
  • Signed written informed consent.

Exclusion Criteria:

  • Blood tests suggestive of other autoimmune diseases
  • Known allergic reaction to MRI contrast media.
  • A clear regression of the neurological symptoms after the first attack that excludes a primary progressive course.
  • Corticosteroid treatment in the previous 4 weeks.
  • Previous treatment with immunosuppressive medications such as cyclophosphamide, azathioprine, methotrexate, mitoxantrone, or cyclosporine.
  • Previous treatment with interferon beta 1a or 1b copolymer-1 IVIg, plasmapheresis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228228


Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Anat Achiron, MD PhD    972-3-5303932    Achiron@post.tau.ac.il   
Contact: Matilda Mandel, MD    972-3-5304081      
Sub-Investigator: Gad Lavie, Dr         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Anat Achiron, MD, PhD Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel
Principal Investigator: Mathilda Mandel, MD Blood Bank, Sheba Medical Center, Tel-Hashomer, Israel
  More Information

ClinicalTrials.gov Identifier: NCT00228228     History of Changes
Other Study ID Numbers: SHEBA-01-2490-AA-CTIL
First Submitted: September 26, 2005
First Posted: September 28, 2005
Last Update Posted: August 29, 2006
Last Verified: August 2006

Keywords provided by Sheba Medical Center:
Multiple Sclerosis
T-cell vaccination
Autoreactive T cells

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs