Hepatitis Clinical Trial
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
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.
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Time Perspective: Prospective
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