Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients (HCVac)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Hepatitis C Infection	Drug: pegylated interferon and ribavirin; Biological: TG4040 + SOC	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Randomized, Multicenter, Open-label Study of TG4040 (MVA-HCV) in Combination With Pegylated Interferon Alfa-2a and Ribavirin Versus Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naïve Patients With Chronic Genotype 1 Hepatitis C.
Study Start Date :	May 2010
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	August 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Arm A; Standard of care (SOC)	Drug: pegylated interferon and ribavirin; 48 weeks
Experimental: Arm B; Vaccine and Standard of care	Biological: TG4040 + SOC; 6 injections
Experimental: Arm C; vaccine and standard of care	Biological: TG4040 + SOC; 13 injections

Outcome Measures

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Primary Outcome Measures :

1. complete early virologic response [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

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Locations

Germany
Hospital
Hannover, Germany

Sponsors and Collaborators

Transgene

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Di Bisceglie AM, Janczweska-Kazek E, Habersetzer F, Mazur W, Stanciu C, Carreno V, Tanasescu C, Flisiak R, Romero-Gomez M, Fich A, Bataille V, Toh ML, Hennequi M, Zerr P, Honnet G, Inchauspé G, Agathon D, Limacher JM, Wedemeyer H. Efficacy of immunotherapy with TG4040, peg-interferon, and ribavirin in a Phase 2 study of patients with chronic HCV infection. Gastroenterology. 2014 Jul;147(1):119-131.e3. doi: 10.1053/j.gastro.2014.03.007. Epub 2014 Mar 18.

Responsible Party:	G Honnet, Transgene
ClinicalTrials.gov Identifier:	NCT01055821 History of Changes
Other Study ID Numbers:	TG4040.02
First Posted:	January 26, 2010
Last Update Posted:	August 13, 2013
Last Verified:	August 2013

Keywords provided by Transgene:

Hepatitis C; Vaccine; HCVac; MVA-HCV

Additional relevant MeSH terms:

Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections	Flaviviridae Infections; Vaccines; Interferons; Ribavirin; Peginterferon alfa-2a; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action