Observational Study of Immune Response to Hepatitis B Childhood Booster
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.
|Study Design:||Observational Model: Cohort|
|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 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||February 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Biological: Engerix B®, a recombinant 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873652
|Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Matthew D Snape, MBBS, FRCPCH||Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ|