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

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