MedTrace Logo

Adolescents' Response to Hepatitis B Vaccine Booster Dose

NCT01341275 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-04-25

No results posted yet for this study

Summary

The aims of this study are to determine:

1. the degree of immunity against hepatitis B,
2. factors associated with immunity against hepatitis B,
3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and
4. if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents.

Study subjects eligible for enrollment will:

* have blood drawn for baseline serologies
* receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose)
* have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine)

The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.

Conditions

Interventions

BIOLOGICAL

hepatitis B vaccine

10 ug dose, one-time administration

BIOLOGICAL

hepatitis B vaccine

20 ug dose, one-time administration

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01341275 on ClinicalTrials.gov