Condition category
Infections and Infestations
Date applied
21/09/2000
Date assigned
21/09/2000
Last edited
02/07/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew J Hall

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17710152

Publication citations

  1. 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.

Additional files

Editorial Notes