Virological Response Study of the HCV Vaccine IC41

Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV

The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.

Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.

Inclusion Criteria:

• Written informed consent obtained prior to study entry
• Patients with chronic hepatitis C; genotype 1
• Treatment naive patients
• Male and Female, 18 to 55 years
• Presence of HLA-A2 marker
• Mentally healthy
• No clinically relevant pathological findings in any of the investigations at screening
• Treatment naive patients with chronic Hepatitis C of genotype 1

Exclusion Criteria:

• Positive results in HIV, HBsAg and HAV-Ag (IgM)
• Other causes of chronic hepatitis
• History of autoimmune diseases
• Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
• Active or passive vaccination 4 weeks before and during the entire study period
• Decompensated liver disease
• History of severe hypersensitivity reactions and anaphylaxis
• Known allergic reactions to one of the components of the vaccine and Imiquimod cream
• Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance
• Malignancies
• Immunosuppressive therapy
• Pregnancy, lactation or breast-feeding
• Unwillingness to practice appropriate contraception
• Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period
• Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)