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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02166671
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Actual Duration (Months): 20.2
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Vaccination	Biological: HBV booster vaccination 1dose	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Humoral and Cellular Immune Responses to a Hepatitis B Vaccine Booster 20-23 Years After Neonatal Immunization
• Actual Study Start Date: Apr 25, 2014
• Actual Primary Completion Date: Dec 31, 2015
• Actual Study Completion Date: Dec 31, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change of HBsAb titer [28 days after HBV booster vaccination]

Secondary Outcome Measures

1. HBsAg-specific cell mediated immunity [28 days after HBV booster vaccination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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(+)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02166671
• Other Study ID Numbers: HBV_VAX_DUR_2014
• First Posted: Jun 18, 2014
• Last Update Posted: May 15, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis

Study Results

No Results Posted as of May 15, 2017