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. 2020 Oct 28;46(1):160.
doi: 10.1186/s13052-020-00923-3.

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

Alberto Berardi  1 , Tiziana Cassetti  2 , Roberta Creti  3 , Caterina Vocale  4 , Simone Ambretti  5 , Mario Sarti  2 , Fabio Facchinetti  6 , Stephen Cose  7   8 ; Prepare Network; Paul Heath  9 , Kirsty Le Doare  10
Collaborators, Affiliations

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

Alberto Berardi et al. Ital J Pediatr. .

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.

Keywords: Group B streptococcus; Meningitis; Newborn; Prevention; Sepsis; Vaccine.

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Conflict of interest statement

The authors declare that they have no competing interests.

Prof Alberto Berardi has received funding from the Institute for Infection and Immunity Paediatric Infectious Diseases Research Group St George’s University of London (UK).

The remaining authors declare they have no funding source.

Financial disclosure: Prof. Alberto Berardi has not received fees.

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