Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00602784
First received: January 4, 2008
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

The objectives are

  1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine.
  2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine.
  3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.

Condition Intervention Phase
Chronic Hepatitis C
Biological: IC41
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized, Multicenter, Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine Together With Polyarginine, HCV Peptide Vaccine Alone, or Polyarginine Alone, in Patients With Chronic HCV Having Not Responded to or Relapsed From Primary Standard HCV Therapy

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Immunological assays [ Time Frame: study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: study duration ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: November 2002
Study Completion Date: September 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IC41-B-01/02
peptide dose 0.00 mg, polyarginine dose 2.00 mg
Biological: IC41
Experimental: IC41-C-01/02
peptide dose: 5.00 mg, polyarginine dose: 0.00 mg
Biological: IC41
Experimental: IC41-G-01/02
peptide dose: 2.50 mg, polyarginine dose: 1.25 mg
Biological: IC41
Experimental: IC41-H-01/02
peptide dose: 2.50 mg, polyarginine dose: 2.00 mg
Biological: IC41
Experimental: IC41-K-01/02
peptide dose: 5.00 mg, polyarginine dose: 2.00 mg
Biological: IC41

Detailed Description:

This is a double blind, randomized, parallel group, controlled, multicenter phase II study.

60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study group will include 8 patients.

Each patient will receive a total of 6 injections according to the dose of the assigned study group. The injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.

The volume of each injection will be 0.5 ml in all groups.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic hepatitis C
  • Non-response to or relapse from primary standard HCV therapy
  • HLA A2 positive
  • HCV-RNA positive
  • HCV antibodies positive
  • Liver biopsy within 30 months prior to inclusion
  • Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal)
  • Male and female
  • From 18 to 65 years
  • Written informed consent obtained prior to study entry

Exclusion Criteria:

  • Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
  • Any liver disease other than hepatitis C
  • History of autoimmune disease
  • Immunodeficiency including post-organ-transplantation
  • HIV infection
  • Immunosuppressive therapy
  • Any acute infections within 4 weeks prior to inclusion
  • History of severe hypersensitivity reactions, anaphylaxis or atopy
  • Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years
  • Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
  • Pregnancy or lactation
  • Unreliable contraception
  • Alcohol consumption
  • Drug abuse or addiction within 12 months prior to inclusion
  • Participation in a methadone program
  • Participation in another study within 1 month prior to enrolment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602784

Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Erich Tauber, M.D. Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00602784     History of Changes
Other Study ID Numbers: IC41-201
Study First Received: January 4, 2008
Last Updated: October 18, 2012
Health Authority: Austria: Agency for Health and Food Safety
Germany: Paul-Ehrlich-Institut
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 August 25, 2014