Trials / Completed
CompletedNCT02692170
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- CHA Vaccine Institute Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CVI-HBV-001 | Investigational Product |
| BIOLOGICAL | Conventional Hepatitis B vaccine (20 μg) | Investigational Product |
Timeline
- Start date
- 2012-12-07
- Primary completion
- 2015-05-28
- Completion
- 2015-05-28
- First posted
- 2016-02-25
- Last updated
- 2023-11-18
Source: ClinicalTrials.gov record NCT02692170. Inclusion in this directory is not an endorsement.