Virological Response Study of the HCV Vaccine IC41

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00601770
First received: January 4, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Biological: IC41
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • HCV-RNA 2 weeks after end of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunological assays and Safety [ Time Frame: until study end ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: February 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IC41
8 injections of 4 x 0.125mL
Biological: IC41
injection

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Dr. Adriana Hristea
Bucharest, Romania, 72204
Prof. Dr. Mircea Diculescu
Bucharest, Romania, 11461
Dr. Adriana Motoc
Bucharest, Romania, 30303
Prof. Dr. Carol Stanciu
Iasi, Romania, 700111
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Sonja Ernsthofer, Mag Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00601770     History of Changes
Other Study ID Numbers: IC41-202
Study First Received: January 4, 2008
Last Updated: February 10, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Romania: Ministry of Public Health
Poland: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014