HealthyNCT00873652
Observational Study of Immune Response to Hepatitis B Childhood Booster
An observational study of Healthy, run by University of Oxford at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 41 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Engerix B®, a recombinant hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children have been recorded as having commenced an accelerated course of HBV vaccine between the years 2000 and 2006
Who may be able to join
- Parent/guardian is willing and able to give informed consent for participation in the study.
- Male or Female, aged 3 years 4 months or above.
- Commenced Hepatitis B post exposure prophylaxis at birth.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Parent/guardian is not willing or able to give informed consent for participation in the study.
- The child is currently enrolled in any other interventional research study
- History of a confirmed anaphylactic reaction to a previous dose of hepatitis B containing vaccine or a confirmed reaction to any component of the vaccine
- Evidence of infection with HBV on previous blood tests.
- Previous receipt of booster doses of HBV vaccine within the 2 years prior to study enrolment.
- Significant renal or hepatic impairment.
- Participant who is terminally ill.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/participant at risk because of participation in the study, or may influence the result of the study, or the patient/participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Engerix B®, a recombinant hepatitis B vaccine
- Keywords
- Hepatitis B vaccine, Booster dose, Persistence, Immune response, Healthy children
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix B®, a recombinant hepatitis B vaccineBiological
Also called Hepatitis B Vaccine (Recombinant)
Single 0.5 ml dose intramuscularly into the deltoid muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately prior to vaccination and 4 weeks post vaccination
Secondary outcomes (3)
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.
Measured: 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.
Measured: immediately prior to vaccination and 4 weeks post-vaccination
To evaluate the serum antiHBs geometric mean concentrations (GMCs) at visit 1 and visit 2.
Measured: immediately prior to vaccination and 4 weeks post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew D Snape, MBBS, FRCPCH, Principal investigator, Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873652
- Sponsor's protocol ID
- OVG 2008/5
- Status last verified
- Dec 2017
- First submitted
- 27 Jan 2009
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Yates TA, Paranthaman K, Yu LM, Davis E, Lang S, Hackett SJ, Welch SB, Pollard AJ, Snape MD. UK vaccination schedule: persistence of immunity to hepatitis B in children vaccinated after perinatal exposure. Arch Dis Child. 2013 Jun;98(6):429-33. doi: 10.1136/archdischild-2012-302153. Epub 2013 Mar 9.
PubMed 23476003
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00873652
- Acronym / sponsor ID
- OVG 2008/5
- Conditions
- Healthy
- Keywords
- Hepatitis B vaccine, Booster dose, Persistence, Immune response, Healthy children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 41 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children have been recorded as having commenced an accelerated course of HBV vaccine between the years 2000 and 2006
Key inclusion criteria (5 listed)
- Parent/guardian is willing and able to give informed consent for participation in the study.
- Male or Female, aged 3 years 4 months or above.
- Commenced Hepatitis B post exposure prophylaxis at birth.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Key exclusion criteria (8 listed)
- Parent/guardian is not willing or able to give informed consent for participation in the study.
- The child is currently enrolled in any other interventional research study
- History of a confirmed anaphylactic reaction to a previous dose of hepatitis B containing vaccine or a confirmed reaction to any component of the vaccine
- Evidence of infection with HBV on previous blood tests.
- Previous receipt of booster doses of HBV vaccine within the 2 years prior to study enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engerix B®, a recombinant hepatitis B vaccineAlso: Hepatitis B Vaccine (Recombinant)Single 0.5 ml dose intramuscularly into the deltoid muscle | Biological | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Background: PubMed 23476003Yates TA, Paranthaman K, Yu LM, Davis E, Lang S, Hackett SJ, Welch SB, Pollard AJ, Snape MD. UK vaccination schedule: persistence of immunity to hepatitis B in children vaccinated after perinatal exposure. Arch Dis Child. 2013 Jun;98(6):429-33. doi: 10.1136/archdischild-2012-302153. Epub 2013 Mar 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Snape, MBBS, FRCPCH principal investigator
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.