NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients

Inclusion Criteria: * HBsAg+ serology for more than 6 months before the beginning of the treatment. In the last six months, according to HBeAg serostatus, for: * HBeAg (-) patients, with a) baseline HBV DNA ≥ 103 and b) raised serum ALT (x \>1 ULN) or significant hepatic necroinflammation and/or fibrosis (HAI-NI\>4 and/or HAI-F \>2) or liver stiffness \>7.2 KPa. * HBeAg (+) patients, with a) baseline HBV DNA ≥ 104 and b) and raised serum ALT (x \>1.5 ULN) or significant hepatic necroinflammation and or fibrosis (HAI-NI\>4 and/or HAI-F \>2) or liver stiffness \>7.2 KPa. * Patients of both sex from 18 to 60 years-old * No specific hepatitis B treatment at least for 6 months previous to the inclusion * Voluntary signed informed consent to participate in the trial Exclusion Criteria: * Condition of HBV asymptomatic carrier or cirrhosis or patients with primary hepatocellular carcinoma * Positive serological markers for hepatitis C * Positive serological markers for HIV * Previous specific anti-hepatitis B treatment in the last 6 months. * Critically ill patient history of heart or renal failure, hypertension, hyperthyroidism, epilepsy, immunodeficiency diseases, malignancies or any non-controlled systemic disease. * Pregnancy or nursing women. Women in fertile age without any contraceptive methods. * Known severe allergic conditions (degree III or IV asthma, urticaria, dermatitis, bronchitis, etc. or hypersensitivity to any of the ingredients present in the preparation). * Severe psychiatric dysfunction or another limitation that prevents the patient's consent. * History of Autoimmune diseases (such as SLE, rheumatoid arthritis, multiple sclerosis, non controlled diabetes mellitus type 1) * History of other hepatic diseases of different etiology (such as alcoholism, autoimmune hepatitis, drug induced hepatitis, Wilson's diseases, hemochromatosis) * History of immune suppressive disorder or administration of immune suppressive-immune modulator drugs (including steroids) during or in the 6 months previous to the study. * Very high transaminase levels at the beginning of treatment (ALT over 500 U/L) suggesting a not stable disease with risk for patient's health or acute flares over 15 times the upper limit of normality.