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

Double Blind, Randomized, Multicenter, Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine Together With Polyarginine, HCV Peptide Vaccine Alone, or Polyarginine Alone, in Patients With Chronic HCV Having Not Responded to or Relapsed From Primary Standard HCV Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00602784

Enrollment

Registered

2008-01-28

Start date

2002-11-30

Completion date

2004-09-30

Last updated

2012-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALIC41

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Immunological assays	study duration

Secondary

Measure	Time frame
Safety	study duration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026