Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
600 participants
OBSERVATIONAL
2020-04-01
2024-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preparing for Maternal GBS Vaccine Trials in Africa
NCT06833957
Development of a Serocorrelate of Protection Against Invasive Group B Streptococcus Disease
NCT04735419
GBS Sero-correlate of Protection
NCT02215226
Neonatal Sepsis and GBS Carriage Study
NCT00861055
Maternal- Fetal Infection
NCT03371056
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. Given the complexity, size and costs associated with a phase III trial, it is generally agreed that indirect evidence (correlates) of protection (CoP), based on immunologic data from vaccine and seroepidemiological studies, opsonophagocytic assays and supported by animal models, could be pivotal for vaccine licensure, with effectiveness subsequently confirmed in post-licensure evaluations.
This study aims 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.
GBS cases will be identified through active surveillance of GBS disease in infants, as part of ongoing epidemiological studies in Uganda, the UK, Italy, France, the Netherlands and Malawi. Upon identification of cases, consent will be requested to obtain a serum sample (1-2 mL of blood collected from infant), the GBS isolate and to collect brief clinical and demographic details. Each site will aim to collect around 50 cases of invasive GBS disease cases (with all samples) over the course of 2 years.
Each site will also recruit approximately 1000 women to have a rectovaginal swab at 35-37 weeks gestation and cord and maternal blood samples at delivery. These women and their infants will be followed up to 90 days of age and considered appropriate controls if the infants are exposed to the same serotype/strain of GBS at delivery as the case - but do not develop GBS the first 90 days of life. We will select 3 controls for every case.
The biorepository will be established at the St George's University of London for all samples from the European Union and Malawi and the MRC/UVRI \& LSHTM Uganda Research Unit for Ugandan samples.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
No interventions assigned to this group
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).
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
90 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MU-JHU CARE
OTHER
MRC/UVRI and LSHTM Uganda Research Unit
OTHER
University of Liverpool
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Azienda Ospedaliero-Universitaria di Modena
OTHER
St George's, University of London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kirsty Le Doare, Prof
Role: PRINCIPAL_INVESTIGATOR
St George's, University of London
Stephen Cose, Dr
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assistance Publique Hopitaux de Paris (AP-HP)
Paris, , France
Azienda Ospedaliero-Universitaria di Modena (AOU)
Modena, , Italy
Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri,
Blantyre, , Malawi
Academisch Medisch Centrum,Universiteit van Amsterdam
Amsterdam, , Netherlands
MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd
Kampala, , Uganda
St George's, University of London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17.0021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.