Multiple SclerosisPhase 3NCT00228228
TCV -01-002: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
A Phase 3 study testing T cell vaccination in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- T cell vaccination
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- May 2002to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Anat Achiron, MD PhD, 972-3-5303932, Achiron@post.tau.ac.il
Matilda Mandel, MD, 972-3-5304081
About this study
Official title: T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
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.
Read the 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
- Being tested
- T cell vaccination
- Keywords
- Multiple Sclerosis, T-cell vaccination, Autoreactive T cells
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T cell vaccinationBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of progression to definite MS (second attack) during the study
Time to progression to definite MS (second attack)
Secondary outcomes (3)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startMay 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Anat Achiron, MD, PhD, Principal investigator, Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, IsraelMathilda Mandel, MD, Principal investigator, Blood Bank, Sheba Medical Center, Tel-Hashomer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228228
- Sponsor's protocol ID
- SHEBA-01-2490-AA-CTIL
- Status last verified
- Aug 2006
- First submitted
- 26 Sep 2005
- Last updated
- 29 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-Cell Vaccination in the Treatment of Probable Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00228228
- Acronym / sponsor ID
- SHEBA-01-2490-AA-CTIL
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, T-cell vaccination, Autoreactive T cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2002
- Study completion
- Dec 2006
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T cell vaccination | Biological | – |
Primary outcome
The rate of progression to definite MS (second attack) during the study
Time to progression to definite MS (second attack)
3 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anat Achiron, MD, PhD principal investigator
Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel
Mathilda Mandel, MD principal investigator
Blood Bank, Sheba Medical Center, Tel-Hashomer, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T cell vaccination in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of progression to definite MS (second attack) during the study. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2006.