T cell vaccination benefits relapsing progressive multiple sclerosis patients: a randomized, double-blind clinical trial

T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinic...

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Published in:	PloS one Vol. 7; no. 12; p. e50478
Main Authors:	Karussis, Dimitrios, Shor, Hagai, Yachnin, Julia, Lanxner, Naama, Amiel, Merav, Baruch, Keren, Keren-Zur, Yael, Haviv, Ofra, Filippi, Massimo, Petrou, Panayiota, Hajag, Shalom, Vourka-Karussis, Urania, Vaknin-Dembinsky, Adi, Khoury, Salim, Abramsky, Oded, Atlan, Henri, Cohen, Irun R, Abulafia-Lapid, Rivka
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 14-12-2012 Public Library of Science (PLoS)
Subjects:	Adult Antigens Biology Biophysics Cell lines Clinical trials Cloning Disease-Free Survival Double-Blind Method Double-blind studies Feasibility studies Female Humans Immunology Irradiation Lymphocytes Lymphocytes - cytology Lymphocytes T Magnetic resonance imaging Male Medical research Medicine Multiple sclerosis Multiple Sclerosis, Chronic Progressive - therapy Myelin Myelin proteolipid protein Myelin Sheath - chemistry Myelin Sheath - metabolism Neurology Nuclear medicine Oligodendrocyte-myelin glycoprotein Pathogenesis Patients Peptides Peptides - chemistry Peripheral blood Phenotype Placebos Proteins Radiation Randomization Recurrence Review boards Safety T cell receptors T cells T-Lymphocytes - cytology Time Factors Vaccination Vaccines Walking Jerusalem Israel Israel
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Abstract	T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30×10(6) T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. ClinicalTrials.gov NCT01448252.
AbstractList	T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30x10.sup.6 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. Background T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. Aim To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. Methodology Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10–30×106 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. Results At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (−0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. Conclusions This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. Trial Registration ClinicalTrials.gov NCT01448252 T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled.To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial.Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30×10(6) T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis.At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly.This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted.ClinicalTrials.gov NCT01448252. T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30×10(6) T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. ClinicalTrials.gov NCT01448252. Background T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. Aim To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. Methodology Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10–30×106 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. Results At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (−0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. Conclusions This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. Trial Registration ClinicalTrials.gov NCT01448252 BACKGROUNDT-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. AIMTo evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. METHODOLOGYTwenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30×10(6) T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. RESULTSAt one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. CONCLUSIONSThis is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. TRIAL REGISTRATIONClinicalTrials.gov NCT01448252. Background T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published clinical trials have been all open-labeled. Aim To evaluate the safety and efficacy of TCV in progressive MS, in a double-blind, controlled clinical trial. Methodology Twenty-six patients with relapsing-progressive MS were enrolled in the study (mean age: 39±9.8 years; mean EDSS: 4.4±1.7). T-cell lines reactive to 9 different peptides of the myelin antigens, MBP, MOG and PLP were raised from the patients' peripheral blood. The patients were randomized into two groups: 19 were treated with TCV (four subcutaneous injections of 10-30x10.sup.6 T-cells, attenuated by irradiation, on days 1, 30, 90 and 180) and 7 patients were treated with sham injections. Twenty-four patients (17 in the TCV group and 7 in the placebo) were eligible for per-protocol analysis. Results At one year following the inclusion, an increase in the EDSS (+0.50) and an increase in 10-meter walking time (+0.18 sec), were observed in the placebo group; in the TCV group there was a decrease in the EDSS (-0.44; p<0.01) and in the 10-meter walking time (0.84 sec; p<0.005). Sixteen of the 17 patients (94.1%) in the TCV group remained relapse-free during the year of the study, as compared to 42.9% in the placebo group (p = 0.01 and p = 0.03 with adjustment). The proportion of patients with any relapse during the year of the study in the TCV-group, was reduced by 89.6%., as compared to the placebo-treated group. MRI parameters did not change significantly. Conclusions This is the first controlled, double-blind trial with TCV in progressive MS. The results demonstrate the feasibility and safety of the procedure, and provide significant indications of clinical efficacy. Further studies with larger groups of subjects are warranted. Trial Registration ClinicalTrials.gov NCT01448252
Audience	Academic
Author	Abramsky, Oded Amiel, Merav Vourka-Karussis, Urania Baruch, Keren Keren-Zur, Yael Cohen, Irun R Vaknin-Dembinsky, Adi Petrou, Panayiota Yachnin, Julia Abulafia-Lapid, Rivka Haviv, Ofra Lanxner, Naama Filippi, Massimo Atlan, Henri Shor, Hagai Hajag, Shalom Karussis, Dimitrios Khoury, Salim
AuthorAffiliation	2 Department of Biophysics and Nuclear Medicine, Human Biology Research Center, Hadassah-Hebrew University Hospital, Jerusalem, Israel 3 San Raffaelle Hospital, MS Center, Milan, Italy 1 Department of Neurology, MS Center and the Agnes-Ginges Center for Neurogenetics, Hadassah-Hebrew University Hospital, Jerusalem, Israel 4 Department of Immunology, The Weizmann Institute of Science, Rehovot, Israel Escola Paulista de Medicina - UNIFESP, Brazil
AuthorAffiliation_xml	– name: 1 Department of Neurology, MS Center and the Agnes-Ginges Center for Neurogenetics, Hadassah-Hebrew University Hospital, Jerusalem, Israel – name: Escola Paulista de Medicina - UNIFESP, Brazil – name: 3 San Raffaelle Hospital, MS Center, Milan, Italy – name: 4 Department of Immunology, The Weizmann Institute of Science, Rehovot, Israel – name: 2 Department of Biophysics and Nuclear Medicine, Human Biology Research Center, Hadassah-Hebrew University Hospital, Jerusalem, Israel
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BackLink	https://www.ncbi.nlm.nih.gov/pubmed/23272061$$D View this record in MEDLINE/PubMed
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Copyright	COPYRIGHT 2012 Public Library of Science 2012 Karussis et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2012 Karussis et al 2012 Karussis et al
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DOI	10.1371/journal.pone.0050478
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DocumentTitleAlternate	T Cell Vaccination Benefits Progressive MS
EISSN	1932-6203
Editor	Basso, Alexandre Salgado
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Notes	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23 Conceived and designed the experiments: RAL IRC HA DK OA. Performed the experiments: HS JY NL MA KB YK-Z OH SK. Analyzed the data: MF AVD UV-K SH PP SK. Wrote the paper: RAL DK IC. Competing Interests: The authors have declared that no competing interests exist.
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Snippet	T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously published... Background T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously... BACKGROUNDT-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously... Background T-cell vaccination (TCV) for multiple sclerosis (MS) refers to treatment with autologous anti-myelin T-cells, attenuated by irradiation. Previously...
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SubjectTerms	Adult Antigens Biology Biophysics Cell lines Clinical trials Cloning Disease-Free Survival Double-Blind Method Double-blind studies Feasibility studies Female Humans Immunology Irradiation Lymphocytes Lymphocytes - cytology Lymphocytes T Magnetic resonance imaging Male Medical research Medicine Multiple sclerosis Multiple Sclerosis, Chronic Progressive - therapy Myelin Myelin proteolipid protein Myelin Sheath - chemistry Myelin Sheath - metabolism Neurology Nuclear medicine Oligodendrocyte-myelin glycoprotein Pathogenesis Patients Peptides Peptides - chemistry Peripheral blood Phenotype Placebos Proteins Radiation Randomization Recurrence Review boards Safety T cell receptors T cells T-Lymphocytes - cytology Time Factors Vaccination Vaccines Walking
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Title	T cell vaccination benefits relapsing progressive multiple sclerosis patients: a randomized, double-blind clinical trial
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