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

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001250

Enrollment

Registered

2014-10-10

Start date

2012-12-14

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : - Experimental (dose): CVI-HBV-001 (5ug, 10ug, 20ug, 40ug) - Active comparator (dose): Second generation Hepatits B vaccine (20ug) - Frequency: 3 times - Vaccinat

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Reactogenicity and safety	—

Secondary

Measure	Time frame
Immunogenicity (seroprotection rate, geometric mean titer)	—

Countries

Korea, Republic of

Contacts

Public ContactHana Park

Bundang CHA General Hospital

Outcome results