A single center, randomized, double blinded phase I/IIa exploratory study to evaluate reactogenicity, safety, immunogenicity and dose-response of a new hepatitis B vaccine in human adult
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
75
Investigational Product
Investigational Product
Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
Occurrence of severe local and/or systemic reactogenicity signs and symptoms measured for 7 days after each vaccination
Time frame: 7 days after each vaccination
Seroprotection rate
Seroprotection (\> 10 mIU/mL of anti-HBs) rate measured 4 weeks after vaccination
Time frame: 4 weeks after vaccination
Antibody titers to HBsAg
Geometric mean titer (GMT, mIU/mL) measured 4 weeks after vaccination
Time frame: 4 weeks after vaccination
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