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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: CVI-HBV-001; Biological: Conventional Hepatitis B vaccine (20 μg)

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CVI-HBV-001 (5 μg); HBV surface antigen 5 μg/dose; Intramuscular injection at 0, 1, 6th month	Biological: CVI-HBV-001; Investigational Product
Experimental: CVI-HBV-001 (10 μg); HBV surface antigen 10 μg/dose; Intramuscular injection at 0, 1, 6th month	Biological: CVI-HBV-001; Investigational Product
Experimental: CVI-HBV-001 (20 μg); HBV surface antigen 20 μg/dose; Intramuscular injection at 0, 1, 6th month	Biological: CVI-HBV-001; Investigational Product
Experimental: CVI-HBV-001 (40 μg); HBV surface antigen 40 μg/dose; Intramuscular injection at 0, 1, 6th month	Biological: CVI-HBV-001; Investigational Product
Active Comparator: Conventional Hepatitis B vaccine (20 μg); HBV surface antigen 20 μg/dose; Intramuscular injection at 0, 1, 6th month	Biological: Conventional Hepatitis B vaccine (20 μg); Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days after each vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection rate	Seroprotection (> 10 mIU/mL of anti-HBs) rate measured 4 weeks after vaccination	4 weeks after vaccination
Antibody titers to HBsAg	Geometric mean titer (GMT, mIU/mL) measured 4 weeks after vaccination	4 weeks after vaccination

Collaborators and Investigators

• Sponsor: CHA Vaccine Institute Co., Ltd.
• Investigators: Principal Investigator: Seong Gyu Hwang, M.D., Ph.D., Bundang CHA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2012
• Primary Completion (Actual): May 28, 2015
• Study Completion (Actual): May 28, 2015

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimated): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B
• Other Study ID Numbers: CVI-HBV-001-CT1201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No