Virological Response Study of the HCV Vaccine IC41

Valneva

Status and phase

Completed

Phase 2

Conditions

Chronic Hepatitis C

Treatments

Biological: IC41

Study type

Interventional

Funder types

Industry

Identifiers

IC41-202

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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)