A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine

• Objectives: To explore the most effective dose of the third generation Hepatitis B vaccine through the evaluation of reactogenicity, safety, and immunogenicity.
• Subjects: Adults having anti-HBs antibody titers less than 10 mIU/mL after 3 previous injections of the conventional Hepatitis B vaccine.
• Study hypothesis: The third generation Hepatitis B vaccine, containing preS antigens in addition to S antigen, has an ability to elicit faster protection and higher antibody titers than the second generation Hepatitis B vaccine in the subjects.

Inclusion criteria

• Adults between 20 and 50 years of age
• Anti-HBs titers < 10 mIU/mL
• Subject is able to provide written informed consent by oneself or legal representative

Exclusion criteria

• Hepatitis B core antibodies positive patient
• Patient has abnormal results in liver-function test
• Patient has active microbial, viral, or fungal infections in need of systemic treatment
• Patient has history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.)
• Patient has seizure disorder required anticonvulsants treatment
• Serious chronic obstructive pulmonary disease patient accompanied hypoxemia
• Uncontrollable diabetic patient
• Uncontrollable hypertension patient
• Patient with known history of HIV, HBV, or HCV infection
• Subject had experience of participating other clinical study or clinical treatment within 30 days before screening
• Subject has hypersensitivity or anaphylactic reaction for HBV vaccine components
• Patient being treated for prolonged immunosuppressive therapy (including steroids)
• Hemodialysis patient
• Subject has continuous drinking (>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
• Subject is pregnant or breastfeeding or intending to become pregnant during the study
• Subject has any other significant findings unacceptable in this study under the opinion of the investigator