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

Chronic Hepatitis B Clinical Trial

Official title:

Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy in Patients Who Have Been Treated With HB110E Hepatitis B DNA Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813487
• Other study ID #: HB110E_PI_PS
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: December 26, 2013
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• HBsAg vaccine with Entecavir

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity: HBV specific T-cell response by ELISPOT	sample for immunologic assay will be collected at each visit; VS(~4week), VT1(0week), VT2(8week), VF(16week. T-cell response will be measured by ex-vivo & cultured ELISPOT.	Change from Baseline in HBV specificic T-cell response at 16 weeks	No
Secondary	HBsAg titer	sample for HBsAg will be collected at each visit; VS(~4week), VT1(0week), VT2(8week), VF(16week. Change from baseline in HBsAg titer will be measured at VF.	Change from baseline in HBsAg titer at 16 weeks	No