A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
- Conditions
- Healthy
- Interventions
- Biological: CVI-HBV-001Biological: Conventional Hepatitis B vaccine (20 μg)
- Registration Number
- NCT02692170
- Lead Sponsor
- CHA Vaccine Institute Co., Ltd.
- Brief Summary
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
- Detailed Description
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CVI-HBV-001 (10 μg) CVI-HBV-001 * HBV surface antigen 10 μg/dose * Intramuscular injection at 0, 1, 6th month CVI-HBV-001 (5 μg) CVI-HBV-001 * HBV surface antigen 5 μg/dose * Intramuscular injection at 0, 1, 6th month CVI-HBV-001 (40 μg) CVI-HBV-001 * HBV surface antigen 40 μg/dose * Intramuscular injection at 0, 1, 6th month Conventional Hepatitis B vaccine (20 μg) Conventional Hepatitis B vaccine (20 μg) * HBV surface antigen 20 μg/dose * Intramuscular injection at 0, 1, 6th month CVI-HBV-001 (20 μg) CVI-HBV-001 * HBV surface antigen 20 μg/dose * Intramuscular injection at 0, 1, 6th month
- Primary Outcome Measures
Name Time Method Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination 7 days after each vaccination Occurrence of severe local and/or systemic reactogenicity signs and symptoms measured for 7 days after each vaccination
- Secondary Outcome Measures
Name Time Method Seroprotection rate 4 weeks after vaccination Seroprotection (\> 10 mIU/mL of anti-HBs) rate measured 4 weeks after vaccination
Antibody titers to HBsAg 4 weeks after vaccination Geometric mean titer (GMT, mIU/mL) measured 4 weeks after vaccination