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Virological Response Study of the HCV Vaccine IC41

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IC41
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Prof. Dr. Ulrich Spengler
  • Prof. Dr. Michael Manns
  • Dr. Granzyna Cholewinska-Szymanska
  • Prof. Dr. Andrzej Gladszy
  • Prof. Dr. Mircea Diculescu
  • Dr. Adriana Motoc
  • Dr. Adriana Hristea
  • Prof. Dr. Carol Stanciu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IC41

Arm Description

8 injections of 4 x 0.125mL

Outcomes

Primary Outcome Measures

HCV-RNA 2 weeks after end of treatment

Secondary Outcome Measures

Immunological assays and Safety

Full Information

First Posted
January 4, 2008
Last Updated
February 10, 2014
Sponsor
Valneva Austria GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00601770
Brief Title
Virological Response Study of the HCV Vaccine IC41
Official Title
Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IC41
Arm Type
Experimental
Arm Description
8 injections of 4 x 0.125mL
Intervention Type
Biological
Intervention Name(s)
IC41
Intervention Description
injection
Primary Outcome Measure Information:
Title
HCV-RNA 2 weeks after end of treatment
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Immunological assays and Safety
Time Frame
until study end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Ernsthofer, Mag
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Prof. Dr. Ulrich Spengler
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Prof. Dr. Michael Manns
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Dr. Granzyna Cholewinska-Szymanska
City
Warzawa
ZIP/Postal Code
01201
Country
Poland
Facility Name
Prof. Dr. Andrzej Gladszy
City
Wroclaw
ZIP/Postal Code
51149
Country
Poland
Facility Name
Prof. Dr. Mircea Diculescu
City
Bucharest
ZIP/Postal Code
11461
Country
Romania
Facility Name
Dr. Adriana Motoc
City
Bucharest
ZIP/Postal Code
30303
Country
Romania
Facility Name
Dr. Adriana Hristea
City
Bucharest
ZIP/Postal Code
72204
Country
Romania
Facility Name
Prof. Dr. Carol Stanciu
City
Iasi
ZIP/Postal Code
700111
Country
Romania

12. IPD Sharing Statement

Learn more about this trial

Virological Response Study of the HCV Vaccine IC41

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