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

 1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization
 with HCV antigen peptide vaccine with polyarginine.

 2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization
 with HCV antigen peptide vaccine with polyarginine.

 3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.
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