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Virological Response Study of the HCV Vaccine IC41

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell AG
ClinicalTrials.gov Identifier:
NCT00601770
First received: January 4, 2008
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Intercell AG:

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

Sponsors and Collaborators
Intercell AG
Investigators
Study Director: Sonja Ernsthofer, Mag Intercell AG
  More Information

No publications provided

Responsible Party: Intercell AG
ClinicalTrials.gov Identifier: NCT00601770     History of Changes
Other Study ID Numbers: IC41-202
Study First Received: January 4, 2008
Last Updated: October 18, 2012
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 May 19, 2013