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

CHA Vaccine Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Biological: Conventional Hepatitis B vaccine (20 μg); Biological: CVI-HBV-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02692170

CVI-HBV-001-CT1201

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 5 patient groups

CVI-HBV-001 (5 μg)

Experimental group

Description:

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

Treatment:

Biological: CVI-HBV-001

CVI-HBV-001 (10 μg)

Experimental group

Description:

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

Treatment:

Biological: CVI-HBV-001

CVI-HBV-001 (20 μg)

Experimental group

Description:

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

Treatment:

Biological: CVI-HBV-001

CVI-HBV-001 (40 μg)

Experimental group

Description:

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

Treatment:

Biological: CVI-HBV-001

Conventional Hepatitis B vaccine (20 μg)

Active Comparator group

Description:

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

Treatment:

Biological: Conventional Hepatitis B vaccine (20 μg)