Multiple SclerosisPhase 1/2NCT00220428
T-Cell Vaccination in Multiple Sclerosis (MS)
A Phase 1/2 study testing T-Cell Vaccination in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- T-Cell Vaccination
- Type of treatment
- Vaccines
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 1998to Dec 2007
- Phase
- Phase 1/2
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Definite MS (post criteria)
- Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years.
- Disease duration > 1 year
- Expanded Disability Status Scale (EDSS) between 0-6
- Brain magnetic resonance imaging (MRI) compatible with MS
- Not involved in any other clinical trials
- No other systemic disease
Who cannot join
- Does not comply with the above
Trial locations and contacts
1 site in 1 country.
Matilda Mandel, MD contact
Israel1 site, 1 recruiting
- Recruiting
Multiple Sclerosis Center
Ramat Gan
Anat Achiron, MD PhD, 972-3-5303932, Achiron@post.tau.ac.il
Matilda Mandel, MD, 972-3-5304081
About this study
Official title: The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial
The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.
Read the detailed description
Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones.
Clinical immunologic and neuroradiologic evaluation.
- Conditions
- Multiple Sclerosis
- Being tested
- T-Cell Vaccination
- Keywords
- T cell
- 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.
safety assessment of T-cell vaccination in nonresponding MS patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 1998
- Study completionDec 2007
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 1/2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Anat Achiron, MD PhD, Principal investigator, Sackler School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220428
- Sponsor's protocol ID
- SHEBA-98-1754-AA-CTIL
- Status last verified
- Jan 2007
- First submitted
- 14 Sep 2005
- Last updated
- 24 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial
- ClinicalTrials.gov ID
- NCT00220428
- Acronym / sponsor ID
- SHEBA-98-1754-AA-CTIL
- Conditions
- Multiple Sclerosis
- Keywords
- T cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 1998
- Study completion
- Dec 2007
- First posted
- 22 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.
The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.
Detailed description
Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones.
Clinical immunologic and neuroradiologic evaluation.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Definite MS (post criteria)
- Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years.
- Disease duration > 1 year
- Expanded Disability Status Scale (EDSS) between 0-6
- Brain magnetic resonance imaging (MRI) compatible with MS
Key exclusion criteria (1 listed)
- Does not comply with the above
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
safety assessment of T-cell vaccination in nonresponding MS patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2007.
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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.
Matilda Mandel, MD contact
Anat Achiron, MD PhD principal investigator
Sackler School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 7 inclusion and 1 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 24 Jan 2007. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Anat Achiron, MD PhD (972-3-5303932, ACHIRON@POST.TAU.AC.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety assessment of T-cell vaccination in nonresponding MS patients. 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 24 Jan 2007.