Clinical trial NCT02692170: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: CHA Vaccine Institute Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-25
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and reactogenicity (including incidence of adverse events and expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
timeFrame: 7 days after each vaccination
Secondary outcomes:
measure: Seroprotection rate
timeFrame: 4 weeks after vaccination
measure: Antibody titers to HBsAg
timeFrame: 4 weeks after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Bundang CHA General Hospital
name: Seong Gyu Hwang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: