Adolescents' Response to Hepatitis B Vaccine Booster Dose (REACH)

April 22, 2011 updated by: Baylor College of Medicine

Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Pediatric Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 16-19 years of age
  • born in the United States
  • received the full hepatitis B vaccination series by 12 months of age
  • received the third dose of hepatitis B vaccine within 10 months of the first dose

Exclusion Criteria:

  • a history of hepatitis B disease
  • being born to a mother with hepatitis B at the time of the participant's birth
  • having received hepatitis B immune globulin as an infant
  • immunosuppression including HIV or chronic/current steroid use (use > 10 days duration within the 3 months of enrollment)
  • renal insufficiency or dialysis
  • pregnancy (due to theoretical risk of different immune response among pregnant females)
  • ever receiving a booster (fourth) dose of hepatitis B vaccine
  • history of allergy to the hepatitis B vaccine
  • receipt of blood products or IgG within 3 months of enrollment
  • having received another vaccine within 2 weeks of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: birth, lower dose booster
Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 10 ug dose of hepatitis B vaccine as a booster
Biological: hepatitis B vaccine
10 ug dose, one-time administration
Other Names:
  • EngerixB
Biological: hepatitis B vaccine
20 ug dose, one-time administration
Other Names:
  • EngerixB
EXPERIMENTAL: birth, higher dose booster
Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 20 ug dose of hepatitis B vaccine as a booster
Biological: hepatitis B vaccine
10 ug dose, one-time administration
Other Names:
  • EngerixB
Biological: hepatitis B vaccine
20 ug dose, one-time administration
Other Names:
  • EngerixB
EXPERIMENTAL: 4 weeks, lower dose booster
Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 10 ug dose of hepatitis B vaccine as a booster
Biological: hepatitis B vaccine
10 ug dose, one-time administration
Other Names:
  • EngerixB
Biological: hepatitis B vaccine
20 ug dose, one-time administration
Other Names:
  • EngerixB
EXPERIMENTAL: 4 weeks, higher dose booster
Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 20 ug dose of hepatitis B vaccine as a booster
Biological: hepatitis B vaccine
10 ug dose, one-time administration
Other Names:
  • EngerixB
Biological: hepatitis B vaccine
20 ug dose, one-time administration
Other Names:
  • EngerixB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anti-HBSAg titers
Time Frame: 13-15 days after enrollment and booster dose
13-15 days after enrollment and booster dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

November 1, 2011

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

April 22, 2011

First Submitted That Met QC Criteria

April 22, 2011

First Posted (ESTIMATE)

April 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2011

Last Update Submitted That Met QC Criteria

April 22, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-26257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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