Hepatitis B Booster Study in Adolescence
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: EngerixB, GlaxoSmithKline Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, single-center, parallel group study of residual HBV seroprotection rates and the capacity of seronegative individuals to respond to a challenge dose of HBV vaccine.
Masking: None (Open Label)
Enrollment: 359.0
Sex: All
Minimum age: 10 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B; Vaccine; Immunogenicity

Summary:

      This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with
      Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B
      disease. Adolescents will be invited to have a blood test and those without a minimal level
      of protection (antibody titer) will be offered a "test" vaccination to see if they still have
      capacity to recall an immune response. About one month later they will get another blood test
      to see if a booster response occurred. A few participants will have lost protection (no
      booster response) and will be offered a second HB vaccination to restore protection. Results
      of this study could influence the way in which children in British Columbia (BC) are
      immunized against HB disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 10-11 or 15-16 years

          -  Written informed assent provided by 10-11 year old participants and consent by their
             parent or legal guardian OR written informed consent provided by a 15-16 year old
             participant.

          -  Subjects whom the investigator believes can and will comply with the requirements of
             the protocol.

          -  General good health

          -  Immunized in BC on the regular schedule with hepatitis B vaccine at approximately 2,
             4, 6 months of age, based on an available immunization record.

        Exclusion Criteria:

          -  Hepatitis B vaccination regimen for infants born to a mother with hepatitis B
             infection (e.g. doses at birth and ages 1 and 6 months, with or without HB immune
             globulin at birth).

          -  Receipt of any additional dose(s) of hepatitis B vaccine beyond infancy.

          -  Systemic hypersensitivity to hepatitis B vaccine or severe reaction to any previous
             dose of hepatitis B vaccine.

          -  Receipt of blood or blood product within 3 months prior to Visit 1.

          -  Immune compromise resulting from disease or immunosuppressive systemic medication use
             within 3 months prior to Visit 1.

          -  Chronic health condition requiring ongoing medical supervision e.g. cystic fibrosis.

          -  Incapacity to provide fully informed assent, resulting from cognitive impairment.

          -  Inadequate participant or parental (when the parent will provide consent) fluency in
             English to provide fully informed consent.