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

Italian Journal of Pediatrics

Fabio Facchinetti¹  Stephen Cose²  Kirsty Le Doare³  Roberta Creti⁴  Paul Heath⁵  Mario Sarti⁶  Tiziana Cassetti⁶  Caterina Vocale⁷  Simone Ambretti⁸  Alberto Berardi⁹ 

[1] Department of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, Italy;MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda;Department of Clinical Research, LSHTM, London, UK;Paediatric Infectious Diseases Research Group, St George’s University of London, London, UK;Reparto di Antibiotico Resistenza e Patogeni Speciali (AR-PS), Dipartimento di Malattie Infettive, Istituto Superiore di Sanità, Rome, Italy;St George’s Vaccine Institute, Institute of Infection and Immunity, St George’s, University of London, London, UK;Unità Operativa di Microbiologia Clinica, Azienda Ospedaliero- Universitaria Policlinico, Modena, Italy;Unità Operativa di Microbiologia Clinica, Centro di Riferimento Regionale per le Emergenze Microbiologiche, (CRREM), Policlinico S. Orsola-Malpighi, Università di Bologna, Bologna, Italy;Unità Operativa di Microbiologia, Azienda Ospedaliero-Universitaria S. Orsola-Malpighi, Bologna, Italy;Unità Operativa di Terapia Intensiva Neonatale, Dipartimento Integrato Materno-Infantile, Azienda Ospedaliero-Universitaria Policlinico, Via del Pozzo, 71, 41124, Modena, Italy;

关键词: streptococcus;    Vaccine;    Newborn;    Sepsis;    Meningitis;    Prevention;   

DOI  :  10.1186/s13052-020-00923-3

来源: Springer

【 摘 要 】

BackgroundGroup 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 bodyThe 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 conclusionPREPARE 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.

【 授权许可】

CC BY