Vaccination of Patients With Stage III or IV Malignant Melanoma With Melanoma Antigen Peptides [Melan-A/Mart-1 Analog (ELA), NY-ESO-1b(A) Analog and MAGE-A10] and Montanide Adjuvant
Current peptide vaccines suffer from low efficiency, since they induce only weak immune
activation. We have recently confirmed that in humans the immune response was readily
detectable in local lymph nodes while no or only weak activation could be identified in
circulating lymphocytes. Increased doses of antigen and adjuvant allow a better extension
from local to systemic immune responses.
- Group 1 : vaccination with Melan-A analog (ELA) peptide + Montanide
- Group 2 : vaccination with Melan-A analog (ELA), NY-ESO-1b analog and MAGE-A10 peptides
+ Montanide
- Group 3: vaccination with Melan-A analog (both EAA and ELA), Mage-A10, NY-ESO-1
peptides+ Montanide + CpG adjuvant
- Group 4: vaccination with Melan-A (ELA), Mage-A10,long NY-ESO-1LP peptides + Montanide
+ CpG
- Group 5: vaccination with Melan-A(both EAA and ELA), Mage-A10, long NY-ESO-1 LP
peptides + Montanide + CpG + low dose rIL-2
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of the vaccination will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale
Change from baseline at day 372
Yes
Olivier Michielin, MD
Principal Investigator
Centre Hospitalier Universitaire Vaudois
Switzerland: Swissmedic
LUD 2001-003
NCT00112242
February 2004
March 2013
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