Abstract |
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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Authors | B Loftus, B Newsom, M Montgomery, K Von Gynz-Rekowski, M Riser, S Inman, P Garces, D Rill, J Zhang, J C Williams |
Journal | Clinical immunology (Orlando, Fla.)
(Clin Immunol)
Vol. 131
Issue 2
Pg. 202-15
(May 2009)
ISSN: 1521-7035 [Electronic] United States |
PMID | 19230777
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Immunologic Factors
- Myelin Basic Protein
- Vaccines
- Vaccines, Attenuated
- Vaccines, Subunit
- tovaxin
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Topics |
- Adult
- Dose-Response Relationship, Drug
- Humans
- Immunologic Factors
(adverse effects, therapeutic use)
- Immunotherapy
(standards)
- Infusions, Subcutaneous
- Multiple Sclerosis, Relapsing-Remitting
(drug therapy, physiopathology)
- Myelin Basic Protein
(genetics, immunology)
- T-Lymphocytes
(immunology)
- Treatment Outcome
- Vaccines
- Vaccines, Attenuated
(therapeutic use)
- Vaccines, Subunit
(adverse effects, therapeutic use)
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