PREvention of invasive Group B Streptococcus disease in young infants: a PAthway for the evaluation and licensuRE of an investigational maternal GBS vaccine (PREPARE GBS)

This protocol, piloted by St George’s, University of London, aims to reduce the proportion of invasive Group B Streptococcal (GBS) infections related to perinatality. GBS is a major cause of neonatal infection in industrialized countries and sub-Saharan Africa. More than 319,000 cases of neonatal GBS infections are reported annually worldwide. GBS is also responsible for 33,000 cases of invasive infections in pregnant and postpartum women, 57,000 stillbirths, and 90,000 infant deaths each year, more than the total number of deaths due to mother-to-child transmission of HIV and more than neonatal deaths due to tetanus and pertussis.

Screening for GBS in women in late pregnancy and administering per-partum antibiotic prophylaxis if positive reduced the incidence of early neonatal GBS infections (occurring in the first week of life) by 80% but had no impact on the incidence of late neonatal GBS infections occurring between 7 and 90 days of life. As such, the development of a GBS vaccine would reduce infant and maternal mortality and premature births by protecting both mothers and infants while avoiding the use of antibiotics. Several candidate vaccines are currently under development.

The National Reference Center for Streptococcus (CNR-Strep), a stakeholder in this project, is providing serum samples with associated epidemiological data, previously biobanked under the ColstreptoB and StreptB17 protocols, to test for seroconversion, an essential step in the development of a GBS vaccine.

This project started in 2019 for 5 years is part of the EDCTP2 program supported by the European Union (grant number RIA2018V-2304 -PREPARE).

To PREPARE website