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VaxTeen Hepatitis B Vaccine Booster Study

This study has been completed.
Sponsor:
Collaborator:
Alaska Native Medical Center
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00144313
First received: September 2, 2005
Last updated: September 20, 2007
Last verified: September 2007
History of Changes
  Purpose

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 Intervention Phase
Hepatitis
 Biological: hepatitis B vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • anti-HBs concentration

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

Estimated Enrollment: 60
Study Start Date: August 2005
Study Completion Date: January 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144313

Locations
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
Investigators
Principal Investigator: Laura L Hammitt, MD Centers for Disease Control and Prevention
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00144313     History of Changes
Other Study ID Numbers: CDC-NCID-4127, U50/CCU022279-01
Study First Received: September 2, 2005
Last Updated: September 20, 2007
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on June 17, 2013