Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001

Exclusion Criteria

• •Pregnant or breast-feeding females, adequate contraception required during the treatment phase
• •History of grass pollen allergy
• •Co-infection with HCV, HDV, HIV
• •History of auto-immune hepatitis
• •Elevated Levels of Alpha-Fetoprotein (AFP) \>100 ng/ml
• •Documented history of decompensated liver disease (albumin \<3.5 g/dl and bilirubin \>1.3 mg/dl)
• •Autoimmune disorders, transplant recipients, use of immunosuppressive or immune modulating agents
• •Oral corticosteroids of 20 mg/week within the past 4 weeks prior to screening
• •History of treatment with PEG-IFN of IFN for at least 1 year prior to screening
• •History of evidence or conditions associated with chronic liver disease
• •Acute fever at time of enrolment
• •History of alcohol abuse
• •Planned administration of a vaccine not foreseen by study protocol in the period starting 30 days before first product administration and during the entire study period with exception of influenza vaccine
• •History of Cancer
• •Other severe co-morbid conditions and concurrent medication making the subject unsuitable for participation
• •blood or plasma donation within 1 month of study enrolement and during the course of the study
• •For all patients with chronic HBV infection:
• •1. Total bilirubin \>2x ULN confirmed by repeat testing within 2 weeks, unless historical documentation of Gilbert's syndrome
• •2. Documented or suspected hepatocelluar carcinoma
• •3. Presence of cholangitis, cholecystitis or bile duct obstruction
• •4. Liver cirrhosis assessed by fibroscan with elastography \<9kPa within the previous 12 months and FIB-score \<3.2 at study entry