Virological Response Study of the HCV Vaccine IC41

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IC41

8 injections of 4 x 0.125mL

Group Type EXPERIMENTAL

IC41

Intervention Type BIOLOGICAL

injection

Interventions

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IC41

injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No