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

Hepatitis B Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02166671
• Other study ID #: HBV_VAX_DUR_2014
• Status: Terminated
• Phase: N/A
• First received: June 16, 2014
• Last updated: May 12, 2017
• Start date: April 25, 2014
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 25 Years

Eligibility

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(+)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccination

Intervention

Biological:
• HBV booster vaccination 1dose

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of HBsAb titer		28 days after HBV booster vaccination
Secondary	HBsAg-specific cell mediated immunity		28 days after HBV booster vaccination