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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692170
• Other study ID #: CVI-HBV-001-CT1201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 7, 2012
• Est. completion date: May 28, 2015

Study information

• Verified date: November 2023
• Source: CHA Vaccine Institute Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 28, 2015
• Est. primary completion date: May 28, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hepatitis B

Intervention

Biological:
• CVI-HBV-001
Investigational Product
• Conventional Hepatitis B vaccine (20 µg)
Investigational Product

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CHA Vaccine Institute Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seroprotection rate	Seroprotection (> 10 mIU/mL of anti-HBs) rate measured 4 weeks after vaccination	4 weeks after vaccination
Secondary	Antibody titers to HBsAg	Geometric mean titer (GMT, mIU/mL) measured 4 weeks after vaccination	4 weeks after vaccination