Group B Streptococcus Carrier in ChildbirthNCT04732026
Serocorrelate of Protection Against GBS (PREPARE WP3)
An observational study of Group B Streptococcus Carrier in Childbirth and Group B Streptococcal Infection, Late-Onset, run by St George's, University of London at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset
- How many people
- 600 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 1 Apr 2020to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 days
- All sexes
- Child
Study population: The study will enroll infant subjects from the general population who are delivered at one of the six hospital sites.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Paris (AP-HP)
Paris
Claire Poyart, Prof., 01 58 41 15 60, claire.poyart@aphp.fr
Asmaa Tazi, 015841156, asmaa.tazi@aphp.fr
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Modena (AOU)
Modena
Alberto Berardi, Prof., Alberto.berardi@unimore.it
Tiziana Cassetti, Dr., +393930413618, tizianacassettibio@gmail.com
Malawi1 site, 1 recruiting
- Recruiting
Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri,
Blantyre
Maryke Nielsen, Dr., +265 (0)1812423, m.nielsen@liverpool.ac.uk
Netherlands1 site, 1 recruiting
- Recruiting
Academisch Medisch Centrum,Universiteit van Amsterdam
Amsterdam
Merijn Bijlsma, Dr., m.bijlsma@amsterdamumc.nl
Uganda1 site, 1 recruiting
- Recruiting
MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd
Kampala
Mary Kyohere, Dr., mkyohere@mujhu.org
Musa Sekikubo, Dr
United Kingdom1 site, 1 recruiting
- Recruiting
St George's, University of London
London
Rakan Musleh, rmusleh@sgul.ac.uk
About this study
Official title: PREPARE Work Package 3 -Development of a Serocorrelate of Protection Against GBS - Protocol Harmonisation.
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.
Read the detailed description
Group B Streptococcus (GBS) causes severe infections in young infants across the world. In 2015 it was estimated that there were at least 319,000 infants under three 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. 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
- 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
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a biobank of at least 150 GBS serotype III cases including both the isolate and associated maternal and infant serum.
Biobank at St George's, University of London
Measured: Over the course of 2 years
Secondary outcomes (5)
To determine the quantity of antibody associated with protection against GBS disease
Geometric mean and median antibody titres will be calculated for cases and controls and comparisons made as appropriate
Measured: Over the course of 2 years
To determine the functional antibody associated with protection against GBS disease.
Samples will be tested using opsonophagocytosis killing assay for both anti-capsular and anti-protein antibodies.
Measured: Over the course of 2 years
To demonstrate the relationship between antibody quantity and function in protection against GBS disease
To directly compare total antibody concentration titers (measured by multiplex LUMINEX) with opsonophagocytosis from functional antibodies at the time of birth and at the time of disease.
Measured: Over the course of 2 years
To refine estimates for serocorrelates of protection against GBS disease.
To provide initial data on the relationship between antibody and invasive GBS disease risk by estimating the odds ratio of invasive GBS disease for antibody concentrations above various thresholds for STIII
Measured: Over the course of 2 years
To provide training to participating African laboratories to assure the quality of sample collection and data curation.
A South-South partnership between Makerere University John Hopkins Research Collaboration (MUJHU),and Malawi-Liverpool-Wellcome Trust Clinical Research Programme (MLW) to optimise the capacity for conducting clinical trials for maternal immunisation in Sub-Saharan Africa
Measured: Over the course of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Apr 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B Streptococcus Carrier in ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- MU-JHU CARE, MRC/UVRI and LSHTM Uganda Research Unit, University of Liverpool, Assistance Publique - Hôpitaux de Paris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Azienda Ospedaliero-Universitaria di Modena
- Responsible party
- Sponsor
- Investigators
- Kirsty Le Doare, Prof, Principal investigator, St George's, University of LondonStephen Cose, Dr, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732026
- Sponsor's protocol ID
- 17.0021
- Status last verified
- Oct 2023
- First submitted
- 26 Jan 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE Work Package 3 -Development of a Serocorrelate of Protection Against GBS - Protocol Harmonisation.
- ClinicalTrials.gov ID
- NCT04732026
- Acronym / sponsor ID
- 17.0021
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- MU-JHU CARE, MRC/UVRI and LSHTM Uganda Research Unit, University of Liverpool, Assistance Publique - Hôpitaux de Paris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Azienda Ospedaliero-Universitaria di Modena
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Group B Streptococcus (GBS) causes severe infections in young infants across the world. In 2015 it was estimated that there were at least 319,000 infants under three 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. 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Age groups
- Child
- Study population
- The study will enroll infant subjects from the general population who are delivered at one of the six hospital sites.
Key inclusion criteria (5 listed)
- Infant 0-90 days of life with GBS identified from a normally sterile site.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish a biobank of at least 150 GBS serotype III cases including both the isolate and associated maternal and infant serum.
Time frame: Over the course of 2 years
Biobank at St George's, University of London
5 secondary outcomes
To determine the quantity of antibody associated with protection against GBS disease
Time frame: Over the course of 2 years
To determine the functional antibody associated with protection against GBS disease.
Time frame: Over the course of 2 years
To demonstrate the relationship between antibody quantity and function in protection against GBS disease
Time frame: Over the course of 2 years
To refine estimates for serocorrelates of protection against GBS disease.
Time frame: Over the course of 2 years
To provide training to participating African laboratories to assure the quality of sample collection and data curation.
Time frame: Over the course of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Group B Streptococcus Carrier in Childbirth
Active, not recruitingObservational study
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Le Doare, Prof principal investigator
St George's, University of London
Stephen Cose, Dr principal investigator
London School of Hygiene and Tropical Medicine
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group B Streptococcus Carrier in Childbirth and Group B Streptococcal Infection, Late-Onset, run by St George's, University of London at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Italy, Malawi, Netherlands, Uganda and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Davies, Dr (+442087255214, hdavies@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish a biobank of at least 150 GBS serotype III cases including both the isolate and associated maternal and infant serum. (time frame: Over the course of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.