Observational Study of Immune Response to Hepatitis B Childhood Booster
Condition: Healthy
MeSH terms: Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      The UK immunisation guidelines recommend that children immunised with an accelerated course
      of hepatitis B vaccine (i.e. vaccination at 0, 1, 2 and 12 months) receive an additional
      booster dose of vaccine in later childhood (usually at 3 1/2 years of age). The primary
      objective of this study is to to assess what proportion of these children have 'protective'
      concentrations (10mIU/ml) of hepatitis B specific antibodies before and after the booster
      dose of hepatitis B vaccine.
    

Detailed description: 
      This is an observational, open label study of children immunised in infancy against Hepatitis
      B virus (HBV),evaluating the persistence of immunity and the immune response to a scheduled
      booster dose of Hepatitis B vaccine.

      Children eligible/overdue for their pre school HBV vaccine booster will be identified by
      reviewing clinical records at the John Radcliffe Hospital. The parents/legal guardians of
      these children will be written to and advised that their child should receive/ have received
      a booster dose of HBV vaccine. This letter will also inform parents/ legal guardians that
      they have the option of participating in this study looking at the persistence of HBV vaccine
      induced antibodies through early childhood and the response to a booster dose of HBV vaccine,
      and that this study will be conducted by the Oxford Vaccine Group in the participants' homes.
      Parents will be advised that if they do not wish to take part in this research study they
      should arrange to contact their GP to discuss whether their child requires a booster dose of
      hepatitis B vaccine.

      For participants the study will consist of two visits at a four week interval(visit 1 and
      visit 2). If the parents/guardians then sign the consent form a medical and immunisation
      history will be taken and a medical examination will be undertaken if indicated. If no
      exclusion criteria are identified, the child will be enrolled in the study. A 6ml blood
      sample will be taken from the child and single booster dose of Hepatitis B vaccine will be
      administered.

      For all children receiving the booster dose of vaccine and their GP, practice nurse and child
      health department will be informed. If the child is also due for their other pre-school
      booster vaccines (the 4 in 1 Diphtheria, tetanus, tetanus and polio vaccine, the combined
      Hib-MenC vaccine and the combined measles, mumps, rubella vaccine (MMR)) these will also be
      offered, but will not form part of the study assessment.

      At the second visit following a confirmation of ongoing consent for the study the first
      eligibility for inclusion will be checked along with the occurrence of any serious adverse
      events, 6mls of blood will be drawn from the participant.

      Blood samples will be used for antibody analysis by ELISA.
    

Intervention name(s): Engerix B®, a recombinant hepatitis B vaccine
Intervention type(s): Biological
Intervention description(s): Single 0.5 ml dose intramuscularly into the deltoid muscle
Other intervention name(s): Hepatitis B Vaccine (Recombinant)
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children have been recorded as having commenced an accelerated course of HBV vaccine
        between the years 2000 and 2006
      
Biospecimen description: 
      Serum
    
Keywords: Hepatitis B vaccine; Booster dose; Persistence; Immune response; Healthy children