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

Virological Response Study of the HCV Vaccine IC41

Sponsors

Lead sponsor: Valneva Austria GmbH

Source Valneva Austria GmbH
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.

Overall Status Completed
Start Date February 2006
Completion Date July 2008
Primary Completion Date July 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
HCV-RNA 2 weeks after end of treatment 2 weeks
Secondary Outcome
Measure Time Frame
Immunological assays and Safety until study end
Enrollment 71
Condition
Intervention

Intervention type: Biological

Intervention name: IC41

Description: injection

Arm group label: IC41

Eligibility

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)

Gender: All

Minimum age: 18 Years

Maximum age: 55 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sonja Ernsthofer, Mag Study Director Valneva Austria GmbH
Location
facility
Prof. Dr. Ulrich Spengler | Bonn, 53105, Germany
Prof. Dr. Michael Manns | Hannover, 30625, Germany
Dr. Granzyna Cholewinska-Szymanska | Warzawa, 01201, Poland
Prof. Dr. Andrzej Gladszy | Wroclaw, 51149, Poland
Prof. Dr. Mircea Diculescu | Bucharest, 11461, Romania
Dr. Adriana Motoc | Bucharest, 30303, Romania
Dr. Adriana Hristea | Bucharest, 72204, Romania
Prof. Dr. Carol Stanciu | Iasi, 700111, Romania
Location Countries

Germany

Poland

Romania

Verification Date

February 2014

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: IC41

Arm group type: Experimental

Description: 8 injections of 4 x 0.125mL

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov