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ISRCTN
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ISRCTN71271385
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DOI
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10.1186/ISRCTN71271385
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised trial of hepatitis B booster vaccination at the age of 13 to 15 years following infant vaccination to assess efficacy against hepatitis B infection and acute hepatitis
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Scientific title
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Acronym
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GHABS
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Serial number at source
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G0000531
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Study hypothesis
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Added as of 23/04/2007:
A booster dose of Hepatitis B Virus (HBV) vaccine 15 years after infant vaccination will increase the magnitude and duration of immune responses (measured two and 52 weeks after the boost).
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Gambia
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Disease/condition/study domain
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Hepatitis B Virus
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Participants - inclusion criteria
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Added as of 23/04/2007:
1. ID and vaccination data matched with Gambia Hepatitis Intervention Study (GHIS) database
2. Born between 1/7/1988 and 31/12/1989
3. Living in selected Health Centre (HC) catchment area's
4. Informed consent participant and parent/guardian
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Participants - exclusion criteria
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Added as of 23/04/2007:
1. No complete informed consent
2. No match found
3. Not fully vaccinated in infancy
4. Not in age range
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Anticipated start date
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01/01/2004
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Added as of 23/04/2007: 500
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Interventions
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Added as of 23/04/2007:
Booster dose HBV vaccine
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Primary outcome measure(s)
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Added as of 23/04/2007:
Anti-HBs titers after one year.
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Secondary outcome measure(s)
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Added as of 23/04/2007:
Proportion without anamnestic response following boosting.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17710152
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Contact name
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Dr
Andrew J
Hall
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Address
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London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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21/09/2000
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Last edited
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02/07/2009
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Date ISRCTN assigned
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21/09/2000
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