A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™

Inclusion Criteria

• Healthy males and females 20 - 40 years of age.
• Subjects who provided written informed consent to participate in the study.
• Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
• No clinically-significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at Screening.
• Women of child-bearing potential had to practice an acceptable method of birth control or practice abstinence during the study period or be surgically sterilized, from Screening visit throughout the vaccination phase and for 28 days after the last injection and agree to undergo repeated pregnancy tests.
• Subjects had to be able to understand the requirements of the study and willing to comply with the requirements of the study.

Exclusion Criteria

• Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the vaccine or may interfere with the subject's compliance or the interpretation of study assessment parameters.
• Any clinically-significant abnormality upon physical examination or in the clinical laboratory tests at Screening visit.
• Treatment with immune suppressive agents.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• History of Hepatitis B virus (HBV) infection or confirmed exposure to HBV
• Previous vaccination against Hepatitis B.
• Positive for HBsAg, anti-HBs antibodies, anti-HBc antibodies, anti-HCV (hepatitis C virus) antibodies or anti- HIV antibodies.
• Drug abuse
• Known hypersensitivity or allergy to any component of the study vaccine.
• Body mass index (BMI) < 18.5 or ≥ 30 kg/m2.
• Known concomitant disease or any other medical condition that is considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments.
• Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration that is considered of significance by the Principal Investigator.
• Female subjects: pregnant, lactating or planning a pregnancy.
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Receipt of blood or immunoglobulin transfusion six months prior to the first vaccine dose and during the course of the trial.
• Unwilling or unable (in the judgment of the investigator) to comply with all the requirements of the protocol.
• Participate in another clinical trial within 3 months prior to first vaccination (calculated from the previous study's last dosing date).