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Virological Response Study of the HCV Vaccine IC41

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00601770
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : February 11, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Biological: IC41 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV
Study Start Date : February 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: IC41
8 injections of 4 x 0.125mL
Biological: IC41

Primary Outcome Measures :
  1. HCV-RNA 2 weeks after end of treatment [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Immunological assays and Safety [ Time Frame: until study end ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00601770

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Prof. Dr. Ulrich Spengler
Bonn, Germany, 53105
Prof. Dr. Michael Manns
Hannover, Germany, 30625
Dr. Granzyna Cholewinska-Szymanska
Warzawa, Poland, 01201
Prof. Dr. Andrzej Gladszy
Wroclaw, Poland, 51149
Prof. Dr. Mircea Diculescu
Bucharest, Romania, 11461
Dr. Adriana Motoc
Bucharest, Romania, 30303
Dr. Adriana Hristea
Bucharest, Romania, 72204
Prof. Dr. Carol Stanciu
Iasi, Romania, 700111
Sponsors and Collaborators
Valneva Austria GmbH
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Study Director: Sonja Ernsthofer, Mag Valneva Austria GmbH
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Responsible Party: Valneva Austria GmbH Identifier: NCT00601770    
Other Study ID Numbers: IC41-202
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic