Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0000531
Study information
Scientific title
Acronym
GHABS
Study hypothesis
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).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hepatitis B Virus
Intervention
Added as of 23/04/2007:
Booster dose HBV vaccine
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Added as of 23/04/2007:
Anti-HBs titers after one year.
Secondary outcome measures
Added as of 23/04/2007:
Proportion without anamnestic response following boosting.
Overall trial start date
01/01/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Added as of 23/04/2007: 500
Participant exclusion criteria
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
Recruitment start date
01/01/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Gambia
Trial participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17710152
Publication citations
-
Results
van der Sande MA, Waight PA, Mendy M, Zaman S, Kaye S, Sam O, Kahn A, Jeffries D, Akum AA, Hall AJ, Bah E, McConkey SJ, Hainaut P, Whittle HC, Long-term protection against HBV chronic carriage of Gambian adolescents vaccinated in infancy and immune response in HBV booster trial in adolescence., PLoS ONE, 2007, 2, 8, e753, doi: 10.1371/journal.pone.0000753.