Healthy
Conditions
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.
Interventions
BIOLOGICALCVI-HBV-001
Investigational Product
BIOLOGICALConventional Hepatitis B vaccine (20 μg)
Investigational Product
Sponsors
CHA Vaccine Institute Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults between 20 and 50 years of age 2. Anti-HBs titers \< 10 mIU/mL 3. Subject is able to provide written informed consent by oneself or legal representative
Exclusion criteria
1. Hepatitis B core antibodies positive patient 2. Patient has abnormal results in liver-function test 3. Patient has active microbial, viral, or fungal infections in need of systemic treatment 4. 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.) 5. Patient has seizure disorder required anticonvulsants treatment 6. Serious chronic obstructive pulmonary disease patient accompanied hypoxemia 7. Uncontrollable diabetic patient 8. Uncontrollable hypertension patient 9. Patient with known history of HIV, HBV, or HCV infection 10. Subject had experience of participating other clinical study or clinical treatment within 30 days before screening 11. Subject has hypersensitivity or anaphylactic reaction for HBV vaccine components 12. Patient being treated for prolonged immunosuppressive therapy (including steroids) 13. Hemodialysis patient 14. Subject has continuous drinking (\>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol 15. Subject is pregnant or breastfeeding or intending to become pregnant during the study 16. Subject has any other significant findings unacceptable in this study under the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed