KCT0001250Completed未知
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
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- CHA Vaccine Institute
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 50(Year) (—)
- Sex
- All
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
Investigators
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