NCT00602784

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	IC41

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-05-01
• Completion: 2004-09-01
• First posted: 2008-01-28
• Last updated: 2012-10-19