Prospects for preventing infant invasive GBS disease through maternal vaccination.

Group B streptococcus (GBS) is a leading cause of neonatal sepsis, with the highest incidence (1.3 per 1000 live births) reported from Africa. Although the incidence of invasive GBS disease is reportedly low in South Asia, there is disconnect between prevalence of maternal recto-vaginal colonization and the incidence of early-onset disease (EOD). This is possibly due to case-ascertainment biases that omit investigation of newborns dying on day-0 of life, which accounts for >90% of EOD. Furthermore, GBS is associated with approximately 15% of all infection related stillbirths. Vaccination of pregnant women with a serotype-specific polysaccharide epitope vaccine could possibly protect against EOD and late-onset disease (LOD) in their infants through transplacental transfer of serotype-specific capsular antibody. Furthermore, vaccination of pregnant women might also protect against impaired neurodevelopment following GBS associated neonatal sepsis, and fetal loss/stillbirths. Licensure of a GBS vaccine might be feasible based on safety evaluation and a sero-correlate of protection, with vaccine effectiveness subsequently being demonstrated in phase IV studies. A randomized-controlled trial would, however, be best suited as a vaccine-probe to fully characterize the contribution of GBS to neonatal sepsis associated morbidity and mortality and adverse fetal outcomes.