Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine

This is a double blind, randomized, parallel group, controlled, multicenter phase II study.

60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study group will include 8 patients.

Each patient will receive a total of 6 injections according to the dose of the assigned study group. The injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.

The volume of each injection will be 0.5 ml in all groups.

Inclusion criteria

• Diagnosis of chronic hepatitis C
• Non-response to or relapse from primary standard HCV therapy
• HLA A2 positive
• HCV-RNA positive
• HCV antibodies positive
• Liver biopsy within 30 months prior to inclusion
• Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal)
• Male and female
• From 18 to 65 years
• Written informed consent obtained prior to study entry

Exclusion criteria

• Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
• Any liver disease other than hepatitis C
• History of autoimmune disease
• Immunodeficiency including post-organ-transplantation
• HIV infection
• Immunosuppressive therapy
• Any acute infections within 4 weeks prior to inclusion
• History of severe hypersensitivity reactions, anaphylaxis or atopy
• Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years
• Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
• Pregnancy or lactation
• Unreliable contraception
• Alcohol consumption
• Drug abuse or addiction within 12 months prior to inclusion
• Participation in a methadone program
• Participation in another study within 1 month prior to enrolment