Hepatitis Clinical Trial
Official title:
Persistence of Antibody and Response to Booster of a Recombinant Hepatitis B Vaccine in Children Who Responded to a Primary Course of 2.5µg Recombinant Hepatitis B Vaccine as Infants
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 13 Years to 16 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | CDC Arctic Investigations Program | Anchorage | Alaska |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | Alaska Native Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | anti-HBs concentration | |||
Secondary | side effects | |||
Secondary | anti-HBc and/or HBsAg following primary vaccine series in infancy |
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