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


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Vaccine Development


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

This study is no longer recruiting patients.

Sponsors and Collaborators: Centers for Disease Control and Prevention
Alaska Native Medical Center
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00141999

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
 Vaccine: hepatitis B vaccine
Phase IV

MedlinePlus related topics:  Hepatitis

Study Type: Observational
Study Design: Natural History, Cross-Sectional, Convenience Sample, Prospective Study

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

Further Study Details: 

Expected Total Enrollment:  400

Study start: May 2001;  Study completion: December 2006
Last follow-up: December 2004;  Data entry closure: December 2005

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   -   14 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Mother HBsAg-positive immunosuppressed

Location Information


Alaska
      Alaska Native Medical Center, Anchorage,  Alaska,  99508,  United States

Study chairs or principal investigators

Anthony Fiore, MD,  Principal Investigator,  Centers for Disease Control and Prevention   

More Information

Study ID Numbers:  CDC-NCID-2998; U50/CCU022279
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00141999
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13


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October 13, 2008



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