Back to results

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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

IC41

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

IC41-B-01/02

IC41-C-01/02

IC41-G-01/02

IC41-H-01/02

IC41-K-01/02

Arm Description

peptide dose 0.00 mg, polyarginine dose 2.00 mg

peptide dose: 5.00 mg, polyarginine dose: 0.00 mg

peptide dose: 2.50 mg, polyarginine dose: 1.25 mg

peptide dose: 2.50 mg, polyarginine dose: 2.00 mg

peptide dose: 5.00 mg, polyarginine dose: 2.00 mg

Outcomes

Primary Outcome Measures

Immunological assays

Secondary Outcome Measures

Safety

Full Information

NCT ID

NCT00602784

First Posted

January 4, 2008

Last Updated

October 18, 2012

Sponsor

Valneva Austria GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00602784

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

May 2004 (Actual)

Study Completion Date

September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Valneva Austria GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

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

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IC41-B-01/02

Arm Type

Experimental

Arm Description

peptide dose 0.00 mg, polyarginine dose 2.00 mg

Arm Title

IC41-C-01/02

Arm Type

Experimental

Arm Description

peptide dose: 5.00 mg, polyarginine dose: 0.00 mg

Arm Title

IC41-G-01/02

Arm Type

Experimental

Arm Description

peptide dose: 2.50 mg, polyarginine dose: 1.25 mg

Arm Title

IC41-H-01/02

Arm Type

Experimental

Arm Description

peptide dose: 2.50 mg, polyarginine dose: 2.00 mg

Arm Title

IC41-K-01/02

Arm Type

Experimental

Arm Description

peptide dose: 5.00 mg, polyarginine dose: 2.00 mg

Intervention Type

Biological

Intervention Name(s)

IC41

Primary Outcome Measure Information:

Title

Immunological assays

Time Frame

study duration

Secondary Outcome Measure Information:

Title

Safety

Time Frame

study duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erich Tauber, M.D.

Organizational Affiliation

Valneva Austria GmbH

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs