NCT01448252

Brief Summary

This is a double blind phase I-II clinical trial with multiple autologous T cell vaccinations using T cell lines reactive to 9 different myelin peptides of MBP, MOG and PLP, in patients with relapsing progressive Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started May 2002

Longer than P75 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

6.3 years

First QC Date

October 5, 2011

Last Update Submit

October 6, 2011

Conditions

Multiple Sclerosis

Keywords

T cell vaccinationImmunotherapyTolerancesafetyclinical efficacy

Outcome Measures

Primary Outcomes (5)

  • EDSS changes

    Follow up in changes in the EDSS score

    one year

  • Relapse rate of MS

    recording of the relapses of MS during the year of the study and the prior to the study

    one year follow up

  • PASAT test

    recording of the performance in the PASAT test during the one year of the study

    one year

  • Nine hole PEG test

    recording of the performance in the Nine hole PEG test test during the one year of the study

    one year

  • timed ten meter walking

    recording of the performance in the timed ten meter walking test during the one year of the study

    one year

Secondary Outcomes (1)

  • Quantitative MRI evaluation

    one year

Study Arms (2)

TCV

ACTIVE COMPARATOR

multiple T cell vaccinations against nine myelin peptides at days 1, 30, 90, 180

Biological: T cell vaccination

Placebo

SHAM COMPARATOR

saline injections subcutaneously at the same 4 time points with active treatment

Biological: multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides)

Interventions

multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides)BIOLOGICAL

multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides at days 1, 30,90,180

Also known as: multiple subcutenous injections of saline at days 1, 30,90,180.
Placebo
T cell vaccinationBIOLOGICAL

Multiple injections of autologous T cell lines reactive to 9 myelin peptides.

TCV

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically definite MS (according to Poser's criteria) of the relapsing-progressive type (RPMS).
  • Age: 18-60.
  • EDSS: 3.0 to 7.0.
  • Disease duration: \> 1 year.
  • MRI of the brain with at least 5 lesions in the white matter (T2 imaging).
  • Failure to benefit from other existing treatments according to the guidelines of the Israeli Ministry of Health.

You may not qualify if:

  • Patients with other systemic active disease.
  • Patients who previously received cellular immunotherapy or who are participating in other experimental protocols.
  • Pregnancy; Pregnant women or women who do not use efficacious contraception (oral contraception, or intra-uterine device).
  • Patients with an additional autoimmune condition unrelated to MS or significant allergy.
  • Patients who cannot fully understand the treatment protocol or are unable to sign the informed consent, or in whom the clinician believes that a follow-up period of at least 12 months will not be possible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Neurology,Hadassah ein-Kerem

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Karussis D, Shor H, Yachnin J, Lanxner N, Amiel M, Baruch K, Keren-Zur Y, Haviv O, Filippi M, Petrou P, Hajag S, Vourka-Karussis U, Vaknin-Dembinsky A, Khoury S, Abramsky O, Atlan H, Cohen IR, Abulafia-Lapid R. T cell vaccination benefits relapsing progressive multiple sclerosis patients: a randomized, double-blind clinical trial. PLoS One. 2012;7(12):e50478. doi: 10.1371/journal.pone.0050478. Epub 2012 Dec 14.

    PMID: 23272061DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dimitrios Karussis, Prof.

    Hadassah Medical Organizatin

    PRINCIPAL INVESTIGATOR

  • Rivka Abulafia-Lapid, PhD

    Hadassah Medical Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Multiple Sclerosis Center

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 7, 2011

Study Start

May 1, 2002

Primary Completion

September 1, 2008

Study Completion

March 1, 2009

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

IL(1)