VaxTeen Hepatitis B Vaccine Booster Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144313
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 21, 2007
Alaska Native Medical Center
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
The purpose of this study is to determine immune status of adolescents who responded to a primary series of recombinant hepatitis B vaccine given at birth and to assess their response to a booster dose of vaccine.

Condition or disease Intervention/treatment Phase
Hepatitis Biological: hepatitis B vaccine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Persistence of Antibody and Response to Booster of a Recombinant Hepatitis B Vaccine in Children Who Responded to a Primary Course of 2.5µg Recombinant Hepatitis B Vaccine as Infants
Study Start Date : August 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. anti-HBs concentration

Secondary Outcome Measures :
  1. side effects
  2. anti-HBc and/or HBsAg following primary vaccine series in infancy

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Eligible children are those who received the 2.5 µg/dose three-dose series of Recombivax HB® with the first dose having been given during the first week of life and the series completed by 9 months. All children were born to HBsAg
  • negative mothers, had no HBsAg-positive persons living in their households at the time of immunization, and had a minimum of one serologic specimen prior to the age of 18 months with results indicating an anti-HBs concentration of ≥10mIU/mL.

Exclusion Criteria:

  • Receipt of a fourth dose of any hepatitis B vaccine
  • History of allergic reaction after receiving hepatitis B vaccine or hypersensitivity to any components of the hepatitis B vaccine used for the booster dose
  • History of hepatitis B virus infection
  • Existence of disease known to affect the immune system (e.g., HIV, AIDS, SCID, chronic renal disease, cancer)
  • Current or recent (within 6 months) receipt of immunomodulatory therapy (e.g., systemic corticosteroids, chemotherapy) or blood products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144313

United States, Alaska
CDC Arctic Investigations Program
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Centers for Disease Control and Prevention
Alaska Native Medical Center
Principal Investigator: Laura L Hammitt, MD Centers for Disease Control and Prevention Identifier: NCT00144313     History of Changes
Other Study ID Numbers: CDC-NCID-4127
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 21, 2007
Last Verified: September 2007

Keywords provided by Centers for Disease Control and Prevention:
hepatitis B
immune memory

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs