Recommendations for vaccine standardization and conduct of DC-trials addressing clinical variables identified in the core discussion group
In ongoing clinical trials (multipeptide loaded cytokine matured moDC +/- CD40L activation in >60 pat.) we have obtained valuable information with high impact on future DC-trials:
1) the presence of 2% DMSO in the thawed final vaccine has no negative impact on the quantity and quality of induced immune responses; thus thawed DMSO containing vials do not have to be centrifuged, but simply diluted;
2) class I peptide loaded cytokine matured DC induce de novo or expand preexisting CD8+ T cell IFN gamma responses in the majority of melanoma patients (>70%), surprisingly without the need for class II peptide loading for T cell help;
3) a statistical analysis of the whole group of vaccinated melanoma patients showed statistically significant DC induced responses towards the antigens gp100.A2, NY-ESO1.A2, MAGE-3.DR11 and MAGE3.DP4.
This information will help finalizing the recommendations for vaccine standardization and conduct of DC-trials addressing clinical variables identified in the core discussion group.
protocol
Clinical protocol
Gerold Schuler
DERMA-ER-DC 04 clinical trial of DC-based therapy of melanoma patients +/- CD40L activation
70 patients, DERMA-ER-DC 04 trial
Dimethyl sulfoxide
Biomaterial
CD40 ligand
Homo sapiens
CD8
T cell
Interferon gamma
gp100 antigen
melanoma antigen MAGE-3