Understanding how to protect infants from Group B Streptococcus disease
Development of a Serocorrelate of Protection Against Invasive Group B Streptococcus Disease
This study is trying to see if the levels of certain antibodies in pregnant women can help protect their babies from a serious infection called Group B Streptococcus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 0 Days and up |
| Sex | All |
| Sponsor | St George's, University of London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04735419 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a correlation between the levels of anti-GBS IgG antibodies in pregnant women and the incidence of invasive Group B Streptococcus (GBS) disease in their infants. By analyzing cord blood samples from a large cohort of mothers and their newborns, the study seeks to identify the necessary antibody levels that could effectively protect infants from GBS infections. The ultimate goal is to inform the development of a vaccine that can be administered to pregnant women, thereby reducing the risk of GBS disease in newborns. The study will involve following approximately 180,000 infants to gather sufficient data on GBS disease cases and healthy controls.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who are willing to provide informed consent and have recently given birth.
Not a fit: Patients who are not pregnant or those whose infants are older than 90 days 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 the incidence of GBS disease in infants.
How similar studies have performed: Other studies have shown promise in developing vaccines against GBS, but this specific approach to identifying protective antibody levels is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Exclusion Criteria: For iGBS disease case recruitment, an infant is not eligible unless a parent/person with parental responsibility gives informed consent For iGBS disease control recruitment, a mother is not eligible unless she gives informed consent.
Where this trial is running
London
- St George's University of London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Paul Heath — St George's, University of London
- Study coordinator: Nadia Azzouzi
- Email: nazzouzi@sgul.ac.uk
- Phone: 02082666488
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.