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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Immunological assays
Time frame: study duration
Safety
Time frame: study duration
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