Phase II Study of Personalized Peptide Vaccination with Both a Hepatitis C Virus-Derived Peptide and Peptides from Tumor-Associated Antigens for the Treatment of HCV-Positive Advanced Hepatocellular Carcinoma Patients

Objective. to evaluate safety and immune responses of personalized peptide vaccination (ppv) for hepatitis c virus- (hcv-) positive advanced hepatocellular carcinoma (hcc). patients and methods. patients diagnosed with hcv-positive advanced hcc were eligible for this study. a maximum of four hla-matched peptides were selected based on the preexisting igg responses specific to 32 different peptides,which consisted of a single hcv-derived peptide at core protein positions 35-44 (c-35) and 31 peptides derived from 15 different tumor-associated antigens (taas),followed by subcutaneous administration once per week for 8 weeks. peptide-specific cytotoxic t lymphocyte (ctl) and igg responses were measured before and after vaccination. results. forty-two patients were enrolled. grade 3 injection site skin reaction was observed in 2 patients,but no other ppv-related severe adverse events were noted. peptide-specific ctl responses before vaccination were observed in only 3 of 42 patients,but they became detectable in 23 of 36 patients tested after vaccination. peptide-specific igg responses were also boosted in 19 of 36 patients. peptide-specific igg1 responses to both c-35 and taa-derived peptides could be potentially prognostic for overall survival. conclusion. further clinical study of ppv would be warranted for hcv-positive advanced hcc,based on the safety and strong immune induction. © 2015 shigeru yutani et al.