Status:
COMPLETED
VaxTeen Hepatitis B Vaccine Booster Study
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Alaska Native Medical Center
Conditions:
Hepatitis
Eligibility:
All Genders
13-16 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine immune status of adolescents who responded to a primary series of recombinant hepatitis B vaccine given at birth and to assess their response to a booster dos...
Detailed Description
In the 1970s, Alaska Natives had the highest rate of hepatitis B virus (HBV) infection in the US. Because of this, routine vaccination for all Alaska Native infants beginning at birth was implemented ...
Eligibility Criteria
Inclusion
- Eligible children are those who received the 2.5 µg/dose three-dose series of Recombivax HB® with the first dose having been given during the first week of life and the series completed by 9 months. All children were born to HBsAg
- negative mothers, had no HBsAg-positive persons living in their households at the time of immunization, and had a minimum of one serologic specimen prior to the age of 18 months with results indicating an anti-HBs concentration of ≥10mIU/mL.
Exclusion
- Receipt of a fourth dose of any hepatitis B vaccine
- History of allergic reaction after receiving hepatitis B vaccine or hypersensitivity to any components of the hepatitis B vaccine used for the booster dose
- History of hepatitis B virus infection
- Existence of disease known to affect the immune system (e.g., HIV, AIDS, SCID, chronic renal disease, cancer)
- Current or recent (within 6 months) receipt of immunomodulatory therapy (e.g., systemic corticosteroids, chemotherapy) or blood products
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00144313
Start Date
August 1 2005
End Date
January 1 2006
Last Update
September 21 2007
Active Locations (1)
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1
CDC Arctic Investigations Program
Anchorage, Alaska, United States, 99508