An observational study in Healthy, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 41 Months to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by University of Oxford · Observational
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 28 is below the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children have been recorded as having commenced an accelerated course of HBV vaccine between the years 2000 and 2006
Exclusion Criteria:
Single 0.5 ml dose intramuscularly into the deltoid muscle
Also known as: Hepatitis B Vaccine (Recombinant)
The percentage of participants completing an accelerated course of hepatitis B vaccination with 10 IU/ml Hepatitis B surface antigen specific antibodies (antiHBs) before and after the 'pre-school' booster dose of Hepatitis B vaccine.
Time frame: immediately prior to vaccination and 4 weeks post vaccination
To evaluate the percentage of participants who had serum antiHBs concentrations < 10 IU/ml at visit 1 who had a rise in serum antiHBs to 10 IU/ml at visit 2.
Time frame: immediately prior to vaccination and 4 weeks post-vaccination
To evaluate the percentage of participants who had serum antiHBs concentrations < 10 IU/ml at visit 1 who had a rise in serum antiHBs to 100 IU/ml at visit 2.
Time frame: immediately prior to vaccination and 4 weeks post-vaccination
To evaluate the serum antiHBs geometric mean concentrations (GMCs) at visit 1 and visit 2.
Time frame: immediately prior to vaccination and 4 weeks post-vaccination
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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University of Oxford