Immune Response to Hepatitis B Virus Booster Vaccination... | NCT02166671

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

NCT02166671

Sponsor

Seoul National University Hospital

Status

Terminated

Last Update Posted

May 15, 2017Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Hepatitis B Vaccination

Interventions

HBV booster vaccination 1dose

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Participants were not recruited promptly

Expanded Access Info

Start Date

Apr 25, 2014Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Jun 16, 2014

First Submission Date that Met QC Criteria

Jun 16, 2014

First Posted Date

Jun 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2017

Last Update Posted Date

May 15, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
HBV booster vaccination	Experimental		Biological: HBV booster vaccination 1dose

Name	Type	Description	Arm Group Labels	Other Names
HBV booster vaccination 1dose	Biological		HBV booster vaccination

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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(+)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea