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CompletedNCT01813487Updated Dec 30, 2013

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

An interventional study of HBsAg vaccine with Entecavir in Chronic Hepatitis B, sponsored by Genexine, Inc.. Completed at 1 site in South Korea. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-12-30.

Sponsored by Genexine, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis B

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03

In context

Hepatitis B, Chronic

954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.

This study's enrollment of 6 is below the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.

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Lead sponsor

Genexine, Inc. is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Other
    HBsAg vaccine with Entecavir

    Drug: HBsAg vaccine with Entecavir

Interventions

  • DrugHBsAg vaccine with Entecavir
06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

07

Study locations

1 site
  • The Catholic University of Korea Seoul St. Mary's Hospital
    Seoul, 137 701, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2013, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2013
First posted
Mar 19, 2013
Start
Feb 2013
Primary completionActual
Jul 2013
CompletionActual
Jul 2013
Last update
Dec 30, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01813487
Lead sponsor
Genexine, Inc.
Responsible party
Sponsor
First posted
Mar 19, 2013
Start date
Feb 2013
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Dec 30, 2013

Study contacts

Seung Yoon, MD
principal investigator · The Catholic University of Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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