Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients
Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients
The primary objective of this protocol is to study the effect of the standard of care in
 hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040
 on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.
Inclusion Criteria:

 -  Chronically infected patients with Hepatitis C virus Genotype 1 (1a or 1b) with
 detectable viremia (HCV RNA in blood) for more than 6 months and naïve to treatment;

 -  Patients must have compensated liver disease, with no history of ascites, jaundice,
 hepatic encephalopathy or bleeding from esophageal or gastric varices requiring
 beta-blockers;

 -  No histological evidence of hepatic cirrhosis (including compensated cirrhosis) based
 on a liver biopsy taken within 24 months prior to baseline; or on a FibroScan®
 performed within 6 months prior to treatment which indicates the absence of liver
 cirrhosis, i.e., stage < F4 (METAVIR); in case of no available results, a liver biopsy
 will be performed prior to treatment;

 -  All laboratory parameters must be grade 0 or 1 (as per CTCAE criteria) except for
 alanine amino-transferase (ALT), aspartate amino-transferase (AST), gamma glutamyl
 transferase (GGT) and alkaline phosphatase (ALP) for which a grade 2 will be allowed
 if stated non clinically significant;

 -  No co-infection with Human Immunodeficiency Virus (HIV) or hepatitis B virus (HBsAg
 positive);

 -  No intravenous (IV) drug or alcohol abuse;

 -  Serum thyroid stimulating hormone (TSH) levels within normal ranges, regardless of
 treatment with L-thyroxin;

 -  Normal electrocardiogram (ECG);

 -  Normal retinal examination (eye fundus) within last 12 months for diabetic patients or
 patients suffering from high blood pressure;

 -  Negative pregnancy test in women of childbearing potential (a woman who is two years
 post-menopausal or surgically sterile is not considered to be of childbearing
 potential);

 -  Female patients and female partners of male patients (if childbearing potency) must
 agree to use two effective methods of birth control during the study and for 6 months
 after the end of treatment. One of the methods needs to be a 'barrier' method (condom
 or diaphragm);

 Exclusion Criteria:

 -  Prior treatment for hepatitis C;

 -  Malignancy within the last 5 years; except for patients with history of squamous cell
 skin cancer or basal cell skin cancer who will be enrolled, unless patients have a
 history of skin cancer at the vaccination site;

 -  Diagnosed or suspected hepatocellular carcinoma;

 -  History of psychiatric conditions including, but not limited to, psychosis, suicidal
 ideations, or major depression. Patients with mild to moderate depression in the past
 and no prior history of suicidal gestures or attempts may be enrolled if, in the
 Investigator's opinion, they are suitable for treatment;

 -  Serious, concomitant medical disorder, including active systemic infection and proven
 or suspected immunosuppressive disorder;

 -  History of immunodeficiency or autoimmune disease including autoimmune hepatitis,
 allogenic transplant, or pre-existing autoimmune or antibody-mediated disease
 including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis,
 multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia;

 -  Administration of any vaccine or immunoglobulin within 30 days before the first dose
 of TG4040 /SOC;

 -  Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3
 congestive heart failure; myocardial infarction within the past 6 months; unstable
 angina; coronary angioplasty within the past 6 months; or uncontrolled arterial or
 ventricular cardiac arrhythmias);

 -  Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs
 (e.g. Cyclosporine) within 2 months prior to first TG4040/SOC administration;
 corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are
 allowed;

 -  Any known allergy to interferon (IFN), RBV and/or their excipients;

 -  Any medical contraindications to IFN and/or RBV;

 -  Any known allergy to eggs;

 -  Women who are breastfeeding;