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

May 12, 2017 updated by: Seoul National University Hospital

Humoral and Cellular Immune Responses to a Hepatitis B Vaccine Booster 20-23 Years After Neonatal Immunization

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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(+)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBV booster vaccination
Biological: HBV booster vaccination 1dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of HBsAb titer
Time Frame: 28 days after HBV booster vaccination
28 days after HBV booster vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
HBsAg-specific cell mediated immunity
Time Frame: 28 days after HBV booster vaccination
28 days after HBV booster vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV_VAX_DUR_2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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