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

NCT ID: NCT00228228

Last Updated: 2006-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2006-12-31

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.

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; T-cell vaccination; Autoreactive T cells

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

T cell vaccination

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Anat Achiron, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel

Mathilda Mandel, MD

Role: PRINCIPAL_INVESTIGATOR

Blood Bank, Sheba Medical Center, Tel-Hashomer, Israel

Locations

Sheba Medical Center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Anat Achiron, MD PhD

Role: primary

Matilda Mandel, MD

Role: backup

Other Identifiers

SHEBA-01-2490-AA-CTIL

Identifier Type: -

Identifier Source: org_study_id