Virological Response Study of the HCV Vaccine IC41

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601770
• Other study ID #: IC41-202
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2008
• Last updated: February 10, 2014
• Start date: February 2006
• Est. completion date: July 2008

Study information

• Verified date: February 2014
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutRomania: Ministry of Public HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• IC41
injection

Locations

Country	Name	City	State
Germany	Prof. Dr. Ulrich Spengler	Bonn
Germany	Prof. Dr. Michael Manns	Hannover
Poland	Dr. Granzyna Cholewinska-Szymanska	Warzawa
Poland	Prof. Dr. Andrzej Gladszy	Wroclaw
Romania	Dr. Adriana Hristea	Bucharest
Romania	Dr. Adriana Motoc	Bucharest
Romania	Prof. Dr. Mircea Diculescu	Bucharest
Romania	Prof. Dr. Carol Stanciu	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

Germany,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV-RNA 2 weeks after end of treatment		2 weeks	Yes
Secondary	Immunological assays and Safety		until study end	Yes