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

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00228228
Collaborator
(none)
80
Enrollment
1
Location
55
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or DiseaseIntervention/TreatmentPhase
  • Biological: T cell vaccination
Phase 3

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
Study Start Date :
May 1, 2002
Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  1. The rate of progression to definite MS (second attack) during the study []

  2. Time to progression to definite MS (second attack) []

Secondary Outcome Measures

  1. Change in the count of new gadolinium (GD) enhancing lesions from two baseline (B) MRIs to the final (F) MRIs []

  2. Change in total volume of new GD enhancing lesions from two baseline MRIs (B) to the final MRIs (F) []

  3. The change in neurological disability as measured by the Expanded Disability Status Scale (EDSS) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Sheba Medical CenterRamat GanIsrael52621

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00228228
Other Study ID Numbers:
  • SHEBA-01-2490-AA-CTIL
First Posted:
Sep 28, 2005
Last Update Posted:
Aug 29, 2006
Last Verified:
Aug 1, 2006

Study Results

No Results Posted as of Aug 29, 2006