This study is an open label, dose escalation study using the classical 3+3 design to determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic hepatitis B patients.
The patients enrolled in the trial will be successively allocated into three cohorts for HB-110 1mg, 2mg, and 4mg in combination with Entecavir according to the classical 3+3 protocol design. They will be administered by Electroporation device. The scheduled assessments and visits will be carried out over three periods: run-in period, treatment period, and follow-up period. The run-in period includes the screening visit where a written informed consent is obtained and the screening period where patients are assessed for eligibility. It will be completed within 14 days prior to Visit 1. The patients meeting inclusion criteria will start the treatment period. During the treatment period, subjects will be administered HB-110 by Electroporation at each visit in combination with antiviral drug, Entecavir. The Follow-up period starts once subjects complete the treatment period and will continue until the follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Each patient will be administered HB-110 by Electroporation for 20 weeks based on the protocol and take one pill of Entecavir(0.5 mg) per day during the study period. The Dose of HB-110 will be determined by the classical 3+3 dose escalation schedule and dose levels are 1mg, 2mg, 4mg respectively. The number of patients will be ranged from 9 to 18.
Seoul St. Mary's Hospital
Seoul, South Korea
Frequency of Adverse Events
Time frame: 1 year
Degree of Adverse Events
Time frame: 1 year
Level of HBV antigen-specific T-cell ex-vivo ELISPOT
Time frame: 1 year
Level of HBV antigen-specific T-cell cultured ELISPOT
Time frame: 1 year
Maintenance of HBeAg seroconversion if they had HBeAg seroconversion at Screening Visit, otherwise occurence of HBeAg seroconversion at Follow-up Visit
Time frame: 1 year
HBsAg loss and HBsAg seroconversion rate at Follow-up Visit
Time frame: 1 year
ALT level
Time frame: 1 year
level of HBsAg titer
Time frame: 1 year
Number of HBV DNA Copies
Time frame: 1 year
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