NCT02166671

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

June 16, 2014

Last Update Submit

May 12, 2017

Conditions

Hepatitis B Vaccination

Outcome Measures

Primary Outcomes (1)

  • change of HBsAb titer

    28 days after HBV booster vaccination

Secondary Outcomes (1)

  • HBsAg-specific cell mediated immunity

    28 days after HBV booster vaccination

Study Arms (1)

HBV booster vaccination

EXPERIMENTAL
Biological: HBV booster vaccination 1dose

Interventions

HBV booster vaccination 1doseBIOLOGICAL
HBV booster vaccination

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults 20-25 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

April 25, 2014

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

KR(1)