Developing a biobank for Group B Streptococcus infections
PREPARE Work Package 3 -Development of a Serocorrelate of Protection Against GBS - Protocol Harmonisation.
St George's, University of London · NCT04732026
This study is trying to collect blood samples from infants with Group B Streptococcus infections and healthy infants to help find ways to develop a vaccine to prevent these infections in newborns.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | N/A to 90 Days |
| Sex | All |
| Sponsor | St George's, University of London (other) |
| Locations | 6 sites (Paris and 5 other locations) |
| Trial ID | NCT04732026 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a biobank of serum samples from infants with serotype III Group B Streptococcus (GBS) disease and matched healthy controls across seven countries. It will involve the collection of clinical information and sera from 150 GBS cases and 450 serotype-matched healthy infants. The study seeks to identify correlates of protection that could inform vaccine development for preventing GBS infections in newborns. By leveraging data from multiple international sites, the study aims to enhance understanding of GBS disease and its prevention.
Who should consider this trial
Good fit: Ideal candidates include infants aged 0-90 days diagnosed with GBS disease and healthy infants born to GBS-colonized mothers who do not develop GBS disease.
Not a fit: Patients who are older than 90 days or those who do not have a parent or guardian willing to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a vaccine that significantly reduces GBS infections in newborns, improving health outcomes for mothers and infants worldwide.
How similar studies have performed: Other studies have shown promise in identifying correlates of protection for various infectious diseases, suggesting that this approach could be beneficial for GBS as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria An infant is not eligible unless a parent/person with parental responsibility gives informed consent.
Where this trial is running
Paris and 5 other locations
- Assistance Publique Hopitaux de Paris (AP-HP) — Paris, France (RECRUITING)
- Azienda Ospedaliero-Universitaria di Modena (AOU) — Modena, Italy (RECRUITING)
- Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri, — Blantyre, Malawi (RECRUITING)
- Academisch Medisch Centrum,Universiteit van Amsterdam — Amsterdam, Netherlands (RECRUITING)
- MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd — Kampala, Uganda (RECRUITING)
- St George's, University of London — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Kirsty Le Doare, Prof — St George's, University of London
- Study coordinator: Hannah Davies, Dr
- Email: hdavies@sgul.ac.uk
- Phone: +442087255214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis, Group B Strep Infection