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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 August 28, 2014