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Immune Response to Hepatitis B Virus Booster Vaccination After 20-23 Years

Primary Purpose

Hepatitis B Vaccination

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HBV booster vaccination 1dose
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B Vaccination

Eligibility Criteria

20 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy adults 20-25 years old

Exclusion Criteria:

  • Hepatitis B surface antigen (+)
  • Hepatitis B core antibody (+)
  • any history of liver disorders including hepatitis
  • HIV Ag or Ab(+)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HBV booster vaccination

Arm Description

Outcomes

Primary Outcome Measures

change of HBsAb titer

Secondary Outcome Measures

HBsAg-specific cell mediated immunity

Full Information

First Posted
June 16, 2014
Last Updated
May 12, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02166671
Brief Title
Immune Response to Hepatitis B Virus Booster Vaccination After 20-23 Years
Official Title
Humoral and Cellular Immune Responses to a Hepatitis B Vaccine Booster 20-23 Years After Neonatal Immunization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Participants were not recruited promptly
Study Start Date
April 25, 2014 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine booster in healthy adults which received a full course of neonatal hepatitis B vaccination 20-23 years ago.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HBV booster vaccination
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
HBV booster vaccination 1dose
Primary Outcome Measure Information:
Title
change of HBsAb titer
Time Frame
28 days after HBV booster vaccination
Secondary Outcome Measure Information:
Title
HBsAg-specific cell mediated immunity
Time Frame
28 days after HBV booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy adults 20-25 years old Exclusion Criteria: Hepatitis B surface antigen (+) Hepatitis B core antibody (+) any history of liver disorders including hepatitis HIV Ag or Ab(+)
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Immune Response to Hepatitis B Virus Booster Vaccination After 20-23 Years

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