An observational study in Streptococcus Agalactiae Infection, sponsored by St George's, University of London. Recruiting at 1 site in United Kingdom. Open to participants aged 0 Days and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by St George's, University of London · Observational
A multicentre study to provide evidence that the relationship between an immune marker value (anti-GBS IgG concentration) and the probability of invasive GBS (iGBS) disease in infants less than 90 days of age is sufficiently strong that a vaccine able to induce an immune response will lead to a meaningful decrease in the probability of iGBS disease.
Group B Streptococcus (GBS) is a bacterium (a bug) that causes serious infections in young infants across the world. In 2015 it was estimated that there were at least 319,000 infants under 3 months of age with GBS disease worldwide, resulting in 90,000 deaths and at least 10,000 children with long term disabilities. Around 20% of all pregnant women carry GBS in their vagina and bowel and babies are exposed to GBS bacteria around the time of birth. The options for prevention are currently limited to offering antibiotics during labour.
A vaccine that could be given to pregnant women has the greatest potential to benefit mothers and babies worldwide. There are vaccines currently being tested in clinical trials, including in pregnant women. The iGBS3 study aims to find out what levels of immunity (usually measured as antibody) a woman needs to pass to her baby to protect the baby from getting GBS disease. This will allow us to predict what antibody level a vaccine has to achieve to be effective and then to get those vaccines licensed and implemented as quickly as possible.
To do this, the study need to take a small sample of cord blood from a very large number of women just after delivering their baby. The study will need to follow around 180 000 babies in order to find at least 170 babies with GBS disease (of which 100 will have disease with the most common type) and compare their levels of antibody in cord blood with 300 healthy babies exposed to the same GBS type. To achieve this, SGUL will work with the Nottingham Clinical Trials Unit to embed this study in their existing GBS3 Trial, in which 80 hospitals across England, Scotland and Wales will be involved for 2 years.
Study Design iGBS3 is a large, multicentre, prospective, unmatched case control study in the UK designed to compare levels of antibody in cord blood in mothers whose infants develop GBS disease (iGBS) and colonised mothers whose infants do not develop GBS disease. To achieve this, the project aim to recruit at least 170 babies with GBS disease (of which 100 will have disease with the most common type) and 300 healthy babies exposed to the same GBS type. An exploratory substudy will look into levels of antibody in cord blood in mothers whose infants develop severe bacterial or viral infections caused by pathogens other than GBS.
Duration The overall duration of the project is planned for 36 months. This includes 2 months set-up, 12 months recruitment for Phase 1, 4 months for interval analysis, 12 months recruitment for Phase 2, 6 months for final retrieval of data, analysis and write-up.
Two phases
146 studies on the registry are indexed under Streptococcal Infections; 14 are open to participants now.
This study's planned enrollment of 400 is close to the median of 400 across 31 observational studies indexed under Streptococcal Infections.
Browse Streptococcal Infections studies →St George's, University of London is the lead sponsor of 106 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women giving birth in maternity units in England, Scotland and Wales participating in the GBS3 study and their infants in the first 3 month of life
Inclusion Criteria:
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Exclusion Criteria:
For iGBS disease case recruitment, an infant is not eligible unless a parent/person with parental responsibility gives For iGBS disease control recruitment, a mother is not eligible unless she gives informed consent.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cases are defined as infants who develop invasive GBS disease (iGBS disease= isolation of GBS from a normally sterile site, i.e. blood or CSF) in the first 90 days of life.
Other: No intervention
Controls are defined as infants who are exposed to the same serotype of GBS at birth as the case - but who do not develop iGBS disease in the first 90 days of life.
Other: No intervention
No intervention
Correlates objective
• To provide initial data on the relationship between antibody and iGBS disease risk by estimating the odds ratio of iGBS disease for antibody concentrations above various thresholds for STIII
Time frame: 36 months
Kinetics objective
• To determine whether antibody concentrations obtained at the time of disease (acute disease sample) can be used to predict cord antibody concentrations at birth in cases of iGBS STIII disease
Time frame: 12 months
Correlates other than STIII
• To provide data on the relationship between antibody and iGBS disease risk by estimating the odds ratio of iGBS disease for antibody concentrations above various thresholds for serotypes other than STIII as well as all serotypes combined
Time frame: 36 months
Kinetics other than STIII
• To determine whether antibody concentrations obtained at the time of disease (acute disease sample) can be used to predict cord antibody concentrations in cases for serotypes others than STIII and to see if any declines differ by serotype
Time frame: 12 months
Controls objective
• To generate sufficient controls of women colonised with STIII and other serotypes
Time frame: 36 months
Risk reduction objective
• To combine case-control study results (odds ratios and antibody RCD curves at different cut-offs) with other data on antibody distribution in the population and iGBS disease risk to determine absolute risk reduction. This could then be combined with vaccine immunologic trial data when available to allow prediction of vaccine efficacy (the decrease in probability of iGBS disease in infants of vaccinated compared to unvaccinated mothers).
Time frame: 36 months
Other pathogens sub-study
• To provide data on the relationship between antibody and infant infections caused by pathogens other than GBS
Time frame: 36 months
Plan to share: Undecided
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