Hepatitis |
viral; Viral Hepatitis |
Clinical Trial: Response to Booster Doses of Hepatitis B Vaccine in Children and Adolescents
This study is no longer recruiting patients.
|
Purpose
| 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
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
Accepts Healthy Volunteers
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
Anthony Fiore, MD, Principal Investigator, Centers for Disease Control and Prevention
More Information
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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