Serocorrelate of Protection Against GBS
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| ClinicalTrials.gov Identifier: NCT04732026 |
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Recruitment Status :
Recruiting
First Posted : February 1, 2021
Last Update Posted : February 1, 2021
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| Condition or disease |
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| 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 |
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 Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | PREPARE Work Package 3 -Development of a Serocorrelate of Protection Against GBS - Protocol Harmonisation. |
| Actual Study Start Date : | April 1, 2020 |
| Estimated Primary Completion Date : | August 1, 2022 |
| Estimated Study Completion Date : | August 1, 2022 |
| Group/Cohort |
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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).
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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).
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- 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
- To determine the quantity of antibody associated with protection against GBS disease [ Time Frame: Over the course of 2 years ]Geometric mean and median antibody titres will be calculated for cases and controls and comparisons made as appropriate
- To determine the functional antibody associated with protection against GBS disease. [ Time Frame: Over the course of 2 years ]Samples will be tested using opsonophagocytosis killing assay for both anti-capsular and anti-protein antibodies.
- To demonstrate the relationship between antibody quantity and function in protection against GBS disease [ Time Frame: Over the course of 2 years ]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.
- To refine estimates for serocorrelates of protection against GBS disease. [ Time Frame: Over the course of 2 years ]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
- 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 ]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
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | up to 90 Days (Child) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732026
| Contact: Hannah Davies, Dr | +442087255214 | hdavies@sgul.ac.uk | |
| Contact: Madeleine Cochet | +442087255214 | mcochet@sgul.ac.uk |
| France | |
| Assistance Publique Hopitaux de Paris (AP-HP) | Recruiting |
| Paris, France | |
| Contact: Claire Poyart, Prof. 01 58 41 15 60 claire.poyart@aphp.fr | |
| Contact: Asmaa Tazi 015841156 asmaa.tazi@aphp.fr | |
| Italy | |
| Azienda Ospedaliero-Universitaria di Modena (AOU) | Recruiting |
| Modena, Italy | |
| Contact: Alberto Berardi, Prof. Alberto.berardi@unimore.it | |
| Contact: Tiziana Cassetti, Dr. +393930413618 tizianacassettibio@gmail.com | |
| Malawi | |
| Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri, | Recruiting |
| Blantyre, Malawi | |
| Contact: Maryke Nielsen, Dr. +265 (0)1812423 m.nielsen@liverpool.ac.uk | |
| Netherlands | |
| Academisch Medisch Centrum,Universiteit van Amsterdam | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Merijn Bijlsma, Dr. m.bijlsma@amsterdamumc.nl | |
| Uganda | |
| MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd | Not yet recruiting |
| Kampala, Uganda | |
| Contact: Mary Kyohere, Dr. mkyohere@mujhu.org | |
| Principal Investigator: Musa Sekikubo, Dr | |
| United Kingdom | |
| St George's, University of London | Not yet recruiting |
| London, United Kingdom | |
| Contact: Rakan Musleh rmusleh@sgul.ac.uk | |
| Principal Investigator: | Kirsty Le Doare, Prof | St George's, University of London | |
| Principal Investigator: | Stephen Cose, Dr | MRC/UVRI & LSHTM Uganda Research Unit |
| Responsible Party: | St George's, University of London |
| ClinicalTrials.gov Identifier: | NCT04732026 |
| Other Study ID Numbers: |
17.0021 |
| First Posted: | February 1, 2021 Key Record Dates |
| Last Update Posted: | February 1, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Infections Communicable Diseases Neonatal Sepsis Streptococcal Infections Disease Attributes Pathologic Processes Sepsis |
Infant, Newborn, Diseases Systemic Inflammatory Response Syndrome Inflammation Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |