Autologous attenuated T-cell vaccine (Tovaxin) dose escalation in multiple sclerosis relapsing-remitting and secondary progressive patients nonresponsive to approved immunomodulatory therapies

An open-label dose escalation study of T-cell vaccination in multiple sclerosis patients was conducted using attenuated myelin reactive T-cells (MRTC) selected with six myelin peptides, two each from MBP, PLP and MOG. The dose range of subcutaneous injections given at weeks 0, 4, 12 and 20 was 6-9E6...

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Veröffentlicht in:Clinical immunology (Orlando, Fla.). - 1999. - 131(2009), 2 vom: 15. Mai, Seite 202-15
1. Verfasser: Loftus, B (VerfasserIn)
Weitere Verfasser: Newsom, B, Montgomery, M, Von Gynz-Rekowski, K, Riser, M, Inman, S, Garces, P, Rill, D, Zhang, J, Williams, J C
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2009
Zugriff auf das übergeordnete Werk:Clinical immunology (Orlando, Fla.)
Schlagworte:Clinical Trial Journal Article Immunologic Factors Myelin Basic Protein Vaccines Vaccines, Attenuated Vaccines, Subunit tovaxin
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520 |a An open-label dose escalation study of T-cell vaccination in multiple sclerosis patients was conducted using attenuated myelin reactive T-cells (MRTC) selected with six myelin peptides, two each from MBP, PLP and MOG. The dose range of subcutaneous injections given at weeks 0, 4, 12 and 20 was 6-9E6, 30-45E6 and 60-90E6 irradiated MRTC. Assessments were over 52 weeks for MRTC levels, EDSS, MSIS-29, brain MRI and relapses. The 30-45E6 dose was the most effective with reductions in MRTC ranging from 92.4% at week 5 to 64.8% at week 52. The reduction in relapses compared to baseline for the M-ITT and evaluable per-protocol analyses were 63.5%, and 85.0% at week 52. The MRI lesions were stable while there was an improvement trend in the EDSS and MSIS-29 physical subscore following the second injection. Adverse events were mild to moderate in intensity with mild injection site reactions occurring with increasing dosage. The mid-dose was selected for further clinical development studies because of the rapid depletion of peripheral blood MRTC and a trend for improvements in clinical outcomes following immunization 
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650 4 |a Journal Article 
650 7 |a Immunologic Factors  |2 NLM 
650 7 |a Myelin Basic Protein  |2 NLM 
650 7 |a Vaccines  |2 NLM 
650 7 |a Vaccines, Attenuated  |2 NLM 
650 7 |a Vaccines, Subunit  |2 NLM 
650 7 |a tovaxin  |2 NLM 
700 1 |a Newsom, B  |e verfasserin  |4 aut 
700 1 |a Montgomery, M  |e verfasserin  |4 aut 
700 1 |a Von Gynz-Rekowski, K  |e verfasserin  |4 aut 
700 1 |a Riser, M  |e verfasserin  |4 aut 
700 1 |a Inman, S  |e verfasserin  |4 aut 
700 1 |a Garces, P  |e verfasserin  |4 aut 
700 1 |a Rill, D  |e verfasserin  |4 aut 
700 1 |a Zhang, J  |e verfasserin  |4 aut 
700 1 |a Williams, J C  |e verfasserin  |4 aut 
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