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Response to Booster Doses of Hepatitis B Vaccine in Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Alaska Native Medical Center
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00141999
First received: September 1, 2005
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to determine the immune response to an additional (booster) dose of hepatitis B vaccine 5-14 years after a three dose series was given


Condition Intervention Phase
Hepatitis
 Biological: hepatitis B vaccine
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Evaluation of Long-Term Protection Against Hepatitis B Virus Infection: Response of Alaska Native Children and Adolescents Who Received the Primary Recombinant Hepatitis B Vaccine Series Beginning at Birth to an Additional Dose of Vaccine

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 400
Study Start Date: May 2001
Study Completion Date: March 2008
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Routine hepatitis B vaccination beginning at birth was provided to Alaska Natives several years before other areas of the United States began routine infant hepatitis B vaccination programs. Follow up studies of hepatitis B immunity among Alaska Native children provide an early opportunity to assess long term protection against hepatitis B virus (HBV) infection for children vaccinated at birth with the currently used recombinant vaccine. This protocol describes an evaluation of long-term protection against HBV infection among children who received the recombinant hepatitis B vaccine beginning at birth, and who currently receive medical care at the Alaska Native Medical Center (ANMC) in Anchorage, Alaska.

The specific objective of this study is to evaluate the immune response to a five microgram dose of recombinant hepatitis B vaccine among 5-6 year old and 10-14 year old children who received the primary recombinant hepatitis B vaccine series beginning at birth. The concentration of antibodies to hepatitis B surface antigen (anti-HBs) will be measured immediately before administering the vaccine, and compared with levels in serum drawn 1, 2 and 4 weeks afterwards. A rapid antibody response (anamnestic response) indicates that immune memory, and therefore immunity to HBV infection, is preserved. The frequency and magnitude of the anamnestic response for the group of older children will be compared to that of the younger group.

Currently, there is no recommendation for a routine booster dose of vaccine after receiving three doses at birth. This study will provide valuable information regarding the need for and response to an additional dose (booster dose) of hepatitis B vaccine among children entering primary school or adolescence. If evidence of waning immune memory (as measured by a delayed or diminished response to the additional dose of vaccine) is found, these two age groups would be the most easily accessible for routine delivery of a booster dose.

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Received 3 doses of hepatitis B vaccine during infancy, beginning at birth

Exclusion Criteria:

Mother HBsAg-positive immunosuppressed

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141999

Locations
United States, Alaska
Alaska Native Medical Center
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Centers for Disease Control and Prevention
Alaska Native Medical Center
Investigators
Principal Investigator: Anthony Fiore, MD Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00141999     History of Changes
Other Study ID Numbers: CDC-NCID-2998, U50/CCU022279
Study First Received: September 1, 2005
Last Updated: September 26, 2012
Health Authority: United States: Federal Government

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

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 May 21, 2013