VaxTeen Hepatitis B Vaccine Booster Study

Completed · Phase 4

Conditions studied: Hepatitis

In brief

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 dose of vaccine.

Key facts

Study ID

NCT00144313

Run by

Centers for Disease Control and Prevention

People needed

60

Starts

2005-08-01

Expected to finish

2006-01-01

Last updated by the study team

2007-09-21

Who can join

Age: 13 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CDC Arctic Investigations Program — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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