Healthy Clinical Trial
Official title:
An Observational Study of Children Immunised in Infancy Against Hepatitis B Virus, Evaluating the Persistence of Immunity and the Immune Response to a Scheduled Booster Dose of Hepatitis B Vaccine
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.
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.
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