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OpenTrials
Completed

NCT Number: NCT01813487

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 137 701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBsAg vaccine with Entecavir

Drug

Primary outcomes

  1. Immunogenicity: HBV specific T-cell response by ELISPOT

    Time frame: Change from Baseline in HBV specificic T-cell response at 16 weeks

    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.

Secondary outcomes

  1. HBsAg titer

    Time frame: Change from baseline in HBsAg titer at 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

Genexine, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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