Virological Response Study of the HCV Vaccine IC41

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Biological: IC41

• Registration Number: NCT00601770
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.

Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-28
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Written informed consent obtained prior to study entry
• Patients with chronic hepatitis C; genotype 1
• Treatment naive patients
• Male and Female, 18 to 55 years
• Presence of HLA-A2 marker
• Mentally healthy
• No clinically relevant pathological findings in any of the investigations at screening
• Treatment naive patients with chronic Hepatitis C of genotype 1

Exclusion Criteria

• Positive results in HIV, HBsAg and HAV-Ag (IgM)
• Other causes of chronic hepatitis
• History of autoimmune diseases
• Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
• Active or passive vaccination 4 weeks before and during the entire study period
• Decompensated liver disease
• History of severe hypersensitivity reactions and anaphylaxis
• Known allergic reactions to one of the components of the vaccine and Imiquimod cream
• Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance
• Malignancies
• Immunosuppressive therapy
• Pregnancy, lactation or breast-feeding
• Unwillingness to practice appropriate contraception
• Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period
• Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IC41	IC41	8 injections of 4 x 0.125mL

Primary Outcome Measures

Name	Time	Method
HCV-RNA 2 weeks after end of treatment	2 weeks

Secondary Outcome Measures

Name	Time	Method
Immunological assays and Safety	until study end

Trial Locations

Locations (8)

Prof. Dr. Andrzej Gladszy; 🇵🇱 Wroclaw, Poland

Dr. Adriana Hristea; 🇷🇴 Bucharest, Romania

Prof. Dr. Carol Stanciu; 🇷🇴 Iasi, Romania

Prof. Dr. Mircea Diculescu; 🇷🇴 Bucharest, Romania

Dr. Granzyna Cholewinska-Szymanska; 🇵🇱 Warzawa, Poland

Dr. Adriana Motoc; 🇷🇴 Bucharest, Romania

Prof. Dr. Michael Manns; 🇩🇪 Hannover, Germany

Prof. Dr. Ulrich Spengler; 🇩🇪 Bonn, Germany