Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genexine, Inc.
• Treatments: Antiviral Agents; Entecavir; Vaccines

Criteria

Inclusion Criteria:

• subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening.

• positive HBsAg at screening

• serum HBV DNA level below 300copies/mL at screening

• ALT level within 2 x ULN at screening

• voluntarily provide the informed consent

Exclusion Criteria:

• participation in other study within 30 days of screening

• subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine.

• any other conditions that are considered inappropriate for the study by the investigator