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Virological Response Study of the HCV Vaccine IC41

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ClinicalTrials.gov Identifier: NCT00601770
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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
Primary Completion Date : July 2008
Study Completion Date : July 2008
Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
Criteria

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)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00601770


Locations
Germany
Prof. Dr. Ulrich Spengler
Bonn, Germany, 53105
Prof. Dr. Michael Manns
Hannover, Germany, 30625
Poland
Dr. Granzyna Cholewinska-Szymanska
Warzawa, Poland, 01201
Prof. Dr. Andrzej Gladszy
Wroclaw, Poland, 51149
Romania
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
Investigators
Study Director: Sonja Ernsthofer, Mag Valneva Austria GmbH
More Information

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00601770     History of Changes
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:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases