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

Genexine

Status: Completed

Conditions: Chronic Hepatitis B

Treatments: Drug: HBsAg vaccine with Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813487

HB110E_PI_PS

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

HBsAg vaccine with Entecavir

Other group

Treatment:

Drug: HBsAg vaccine with Entecavir