A study to evaluate the reactogenicity, safety, and immunogenicity of the third generation hepatitis B vaccine

Not Applicable

Completed

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0001250
• Lead Sponsor: CHA Vaccine Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reactogenicity and safety

Secondary Outcome Measures

Name	Time	Method
Immunogenicity (seroprotection rate, geometric mean titer)