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Completed

NCT Number: NCT00601770

Virological Response Study of the HCV Vaccine IC41

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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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prof. Dr. Ulrich Spengler, Bonn, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IC41

Biological

injection

Primary outcomes

  1. HCV-RNA 2 weeks after end of treatment

    Time frame: 2 weeks

Secondary outcomes

  1. Immunological assays and Safety

    Time frame: until study end

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 28, 2008
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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