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The Italian arm of the PREPARE study: an international project to evaluate and license a maternal vaccine against group B streptococcus.

Berardi, A; Cassetti, T; Creti, R; Vocale, C; Ambretti, S; Sarti, M; Facchinetti, F; Cose, S; Prepare Network, ; Heath, P; et al. Berardi, A; Cassetti, T; Creti, R; Vocale, C; Ambretti, S; Sarti, M; Facchinetti, F; Cose, S; Prepare Network; Heath, P; Le Doare, K (2020) The Italian arm of the PREPARE study: an international project to evaluate and license a maternal vaccine against group B streptococcus. Ital J Pediatr, 46 (1). p. 160. ISSN 1824-7288 https://doi.org/10.1186/s13052-020-00923-3
SGUL Authors: Le Doare, Kirsty

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Abstract

BACKGROUND: Group B streptococcus (GBS) is a leading cause of sepsis, pneumonia and meningitis in infants, with long term neurodevelopmental sequelae. GBS may be associated with poor pregnancy outcomes, including spontaneous abortion, stillbirth and preterm birth. Intrapartum antibiotic prophylaxis (IAP) is currently the only way to prevent early-onset disease (presenting at 0 to 6 days of life), although it has no impact on the disease presenting over 6 days of life and its implementation is challenging in resource poor countries. A maternal vaccine against GBS could reduce all GBS manifestations as well as improve pregnancy outcomes, even in low-income countries. MAIN BODY: The term "PREPARE" designates an international project aimed at developing a maternal vaccination platform to test vaccines against neonatal GBS infections by maternal immunization. It is a non-profit, multi-center, interventional and experimental study (promoted by the St George University of London. [UK]) with the aim of developing a maternal vaccination platform, determining pregnancy outcomes, and defining the extent of GBS infections in children and mothers in Africa. PREPARE also aims to estimate the protective serocorrelates against the main GBS serotypes that cause diseases in Europe and Africa and to conduct two trials on candidate GBS vaccines. PREPARE consists of 6 work packages. In four European countries (Italy, UK, Netherlands, France) the recruitment of cases and controls will start in 2020 and will end in 2022. The Italian PREPARE network includes 41 centers. The Italian network aims to collect: GBS isolates from infants with invasive disease, maternal and neonatal sera (cases); cord sera and GBS strains from colonized mothers whose infants do not develop GBS infection (controls). SHORT CONCLUSION: PREPARE will contribute information on protective serocorrelates against the main GBS serotypes that cause diseases in Europe and Africa. The vaccine that will be tested by the PREPARE study could be an effective strategy to prevent GBS disease.

Item Type: Article
Additional Information: © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords: Group B streptococcus, Meningitis, Newborn, Prevention, Sepsis, Vaccine, Prepare Network, 1114 Paediatrics and Reproductive Medicine, Pediatrics
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Ital J Pediatr
ISSN: 1824-7288
Language: eng
Dates:
DateEvent
28 October 2020Published
19 October 2020Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
RIA2018V-2304 PREPARE RIA2018VEuropean and Developing Countries Clinical Trials PartnershipUNSPECIFIED
PubMed ID: 33115542
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/112560
Publisher's version: https://doi.org/10.1186/s13052-020-00923-3

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