A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CVI-HBV-001
Conventional Hepatitis B vaccine (20 μg)
Sponsored by
About this trial
This is an interventional prevention trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
CVI-HBV-001 (5 μg)
CVI-HBV-001 (10 μg)
CVI-HBV-001 (20 μg)
CVI-HBV-001 (40 μg)
Conventional Hepatitis B vaccine (20 μg)
Arm Description
HBV surface antigen 5 μg/dose Intramuscular injection at 0, 1, 6th month
HBV surface antigen 10 μg/dose Intramuscular injection at 0, 1, 6th month
HBV surface antigen 20 μg/dose Intramuscular injection at 0, 1, 6th month
HBV surface antigen 40 μg/dose Intramuscular injection at 0, 1, 6th month
HBV surface antigen 20 μg/dose Intramuscular injection at 0, 1, 6th month
Outcomes
Primary Outcome Measures
Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 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
Seroprotection rate
Seroprotection (> 10 mIU/mL of anti-HBs) rate measured 4 weeks after vaccination
Antibody titers to HBsAg
Geometric mean titer (GMT, mIU/mL) measured 4 weeks after vaccination
Full Information
NCT ID
NCT02692170
First Posted
February 18, 2016
Last Updated
February 22, 2016
Sponsor
CHA Vaccine Institute Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02692170
Brief Title
A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
Official Title
A Single Center, Randomized, Double Blinded PhaseI/IIa Exploratory Study to Evaluate Reactogenicity, Safety, Immunogenicity and Dose Response of a New Hepatitis B Vaccine in Human Adult
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHA Vaccine Institute Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVI-HBV-001 (5 μg)
Arm Type
Experimental
Arm Description
HBV surface antigen 5 μg/dose
Intramuscular injection at 0, 1, 6th month
Arm Title
CVI-HBV-001 (10 μg)
Arm Type
Experimental
Arm Description
HBV surface antigen 10 μg/dose
Intramuscular injection at 0, 1, 6th month
Arm Title
CVI-HBV-001 (20 μg)
Arm Type
Experimental
Arm Description
HBV surface antigen 20 μg/dose
Intramuscular injection at 0, 1, 6th month
Arm Title
CVI-HBV-001 (40 μg)
Arm Type
Experimental
Arm Description
HBV surface antigen 40 μg/dose
Intramuscular injection at 0, 1, 6th month
Arm Title
Conventional Hepatitis B vaccine (20 μg)
Arm Type
Active Comparator
Arm Description
HBV surface antigen 20 μg/dose
Intramuscular injection at 0, 1, 6th month
Intervention Type
Biological
Intervention Name(s)
CVI-HBV-001
Intervention Description
Investigational product: CVI-HBV-001
Dose: 5, 10, 20 or 40ug
Frequency: 3 times
Vaccination schedule: at 0, 1, 6 months
Administration route: Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Conventional Hepatitis B vaccine (20 μg)
Intervention Description
Active comparator: Conventional Hepatitis B vaccine (20 μg)
Dose: 20ug
Frequency: 3 times
Vaccination schedule: at 0, 1, 6 months
Administration route: Intramuscular injection
Primary Outcome Measure Information:
Title
Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
Description
Occurrence of severe local and/or systemic reactogenicity signs and symptoms measured for 7 days after each vaccination
Time Frame
7 days after each vaccination
Secondary Outcome Measure Information:
Title
Seroprotection rate
Description
Seroprotection (> 10 mIU/mL of anti-HBs) rate measured 4 weeks after vaccination
Time Frame
4 weeks after vaccination
Title
Antibody titers to HBsAg
Description
Geometric mean titer (GMT, mIU/mL) measured 4 weeks after vaccination
Time Frame
4 weeks after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong Gyu Hwang, M.D., Ph.D.
Organizational Affiliation
Bundang CHA General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
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