A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
NCT ID: NCT02692170
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2012-12-07
2015-05-28
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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CVI-HBV-001 (5 μg)
* HBV surface antigen 5 μg/dose
* Intramuscular injection at 0, 1, 6th month
CVI-HBV-001
Investigational Product
CVI-HBV-001 (10 μg)
* HBV surface antigen 10 μg/dose
* Intramuscular injection at 0, 1, 6th month
CVI-HBV-001
Investigational Product
CVI-HBV-001 (20 μg)
* HBV surface antigen 20 μg/dose
* Intramuscular injection at 0, 1, 6th month
CVI-HBV-001
Investigational Product
CVI-HBV-001 (40 μg)
* HBV surface antigen 40 μg/dose
* Intramuscular injection at 0, 1, 6th month
CVI-HBV-001
Investigational Product
Conventional Hepatitis B vaccine (20 μg)
* HBV surface antigen 20 μg/dose
* Intramuscular injection at 0, 1, 6th month
Conventional Hepatitis B vaccine (20 μg)
Investigational Product
Interventions
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CVI-HBV-001
Investigational Product
Conventional Hepatitis B vaccine (20 μg)
Investigational Product
Eligibility Criteria
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Inclusion Criteria
2. Anti-HBs titers \< 10 mIU/mL
3. Subject is able to provide written informed consent by oneself or legal representative
Exclusion Criteria
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
20 Years
50 Years
ALL
Yes
Sponsors
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CHA Vaccine Institute Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Seong Gyu Hwang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Bundang CHA General Hospital
Other Identifiers
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CVI-HBV-001-CT1201
Identifier Type: -
Identifier Source: org_study_id
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