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)

Enrollment

Location

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 Disease	Intervention/Treatment	Phase
Multiple Sclerosis	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

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Ramat Gan		Israel	52621

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