PREPARE Work Package 3 -Development of a Serocorrelate of Protection Against GBS - Protocol Harmonisation.
Status: Unknown
Location: See all (6) locations...
Study Type: Observational
SUMMARY
A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and France), with 3:1 (450) serotype matched healthy controls.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 months
View:
• Cases:
• Infant 0-90 days of life with GBS identified from a normally sterile site.
• Controls:
• Healthy infant born to a GBS colonised woman that does not develop GBS disease between birth and 90 days of life.
Locations
Other Locations
France
Assistance Publique Hopitaux de Paris (AP-HP)
RECRUITING
Paris
Italy
Azienda Ospedaliero-Universitaria di Modena (AOU)
RECRUITING
Modena
Malawi
Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri,
RECRUITING
Blantyre
Netherlands
Academisch Medisch Centrum,Universiteit van Amsterdam
RECRUITING
Amsterdam
Uganda
MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd
RECRUITING
Kampala
United Kingdom
St George's, University of London
RECRUITING
London
Contact Information
Primary
Hannah Davies, Dr
hdavies@sgul.ac.uk
+442087255214
Backup
Madeleine Cochet
mcochet@sgul.ac.uk
+442087255214
Time Frame
Start Date: 2020-04-01
Completion Date: 2024-04-01
Participants
Target number of participants: 600
Treatments
Cases
150 infants with invasive serotype III GBS disease (isolation of GBS from a normally sterile site, i.e. blood or CSF) in the first 90 days of life from six countries (Malawi, Uganda, UK, the Netherlands, Italy and France).
Controls
450 infants exposed to serotype III GBS at birth - but who do not develop invasive GBS disease in the first 90 days of life from six countries (Malawi, Uganda, UK, the Netherlands, Italy and France).
Related Therapeutic Areas
Sponsors
Collaborators: University of Liverpool, Assistance Publique - Hôpitaux de Paris, MRC/UVRI and LSHTM Uganda Research Unit, Azienda Ospedaliero-Universitaria di Modena, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), MU-JHU CARE
Leads: St George's, University of London