Virological Response Study of the HCV Vaccine IC41

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00601770

Enrollment

Registered

2008-01-28

Start date

2006-02-28

Completion date

2008-07-31

Last updated

2014-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

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.

Interventions

BIOLOGICALIC41

injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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)

Design outcomes

Primary

Measure	Time frame
HCV-RNA 2 weeks after end of treatment	2 weeks

Secondary

Measure	Time frame
Immunological assays and Safety	until study end

Countries

Germany, Poland, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026