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

September 1, 2005
September 26, 2012
May 2001
March 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00141999 on ClinicalTrials.gov Archive Site
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Response to Booster Doses of Hepatitis B Vaccine in Children and Adolescents
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

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

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.

Observational
Time Perspective: Prospective
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Hepatitis
Biological: hepatitis B vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
March 2008
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Mother HBsAg-positive immunosuppressed

Both
5 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141999
CDC-NCID-2998, U50/CCU022279
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Alaska Native Medical Center
Principal Investigator: Anthony Fiore, MD Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP