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

NCT00602784 | Completed Phase 2

• 1 other identifier: IC41-201
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives are

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

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Immunological assays

  study duration

Secondary Outcomes (1)

• Safety

  study duration

Study Arms (5)

IC41-B-01/02

EXPERIMENTAL

peptide dose 0.00 mg, polyarginine dose 2.00 mg

Biological: IC41

IC41-C-01/02

EXPERIMENTAL

peptide dose: 5.00 mg, polyarginine dose: 0.00 mg

Biological: IC41

IC41-G-01/02

EXPERIMENTAL

peptide dose: 2.50 mg, polyarginine dose: 1.25 mg

Biological: IC41

IC41-H-01/02

EXPERIMENTAL

peptide dose: 2.50 mg, polyarginine dose: 2.00 mg

Biological: IC41

IC41-K-01/02

EXPERIMENTAL

peptide dose: 5.00 mg, polyarginine dose: 2.00 mg

Biological: IC41

Interventions

IC41 BIOLOGICAL

IC41-B-01/02; IC41-C-01/02; IC41-G-01/02; IC41-H-01/02; IC41-K-01/02

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic hepatitis C
• Non-response to or relapse from primary standard HCV therapy
• HLA A2 positive
• HCV-RNA positive
• HCV antibodies positive
• 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

You may not qualify if:

• 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
• 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
• Participation in a methadone program
• Participation in another study within 1 month prior to enrolment

Sponsors & Collaborators

• Valneva Austria GmbH: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Erich Tauber, M.D.

  Valneva Austria GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 28, 2008
• Study Start: November 1, 2002
• Primary Completion: May 1, 2004
• Study Completion: September 1, 2004
• Last Updated: October 19, 2012

Record last verified: 2012-10