Trial | NCT02692170  Report issue

Title

A Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of the Third Generation Hepatitis B Vaccine
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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    75
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
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.
Study Started
Dec 07
2012
Primary Completion
May 28
2015
Study Completion
May 28
2015
Last Update
Nov 18
2023

Biological CVI-HBV-001

Investigational Product

Biological Conventional Hepatitis B vaccine (20 μg)

Investigational Product

CVI-HBV-001 (5 μg) Experimental

HBV surface antigen 5 μg/dose Intramuscular injection at 0, 1, 6th month

CVI-HBV-001 (10 μg) Experimental

HBV surface antigen 10 μg/dose Intramuscular injection at 0, 1, 6th month

CVI-HBV-001 (20 μg) Experimental

HBV surface antigen 20 μg/dose Intramuscular injection at 0, 1, 6th month

CVI-HBV-001 (40 μg) Experimental

HBV surface antigen 40 μg/dose Intramuscular injection at 0, 1, 6th month

Conventional Hepatitis B vaccine (20 μg) Active Comparator

HBV surface antigen 20 μg/dose Intramuscular injection at 0, 1, 6th month

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
No Results Posted