Abstract

Group B Streptococcus (GBS) is estimated to have caused 319,000 cases of neonatal disease resulting in 90,000 infant deaths globally in 2015. It is also associated with maternal sepsis, preterm births, stillbirths and neonatal encephalopathy. There is a significant burden of neurologic impairment among survivors of infant GBS disease. Intrapartum antibiotic prophylaxis strategies have reduced the incidence of newborn early-onset GBS (occurring days 0-6) in some settings, but they are not feasible in many low and middle-income countries. A maternal vaccine given to pregnant women to stimulate passive transplacental transfer of protective antibodies has the potential to reduce maternal disease, adverse pregnancy outcomes and newborn disease. Phase I and II vaccine studies are occurring, but conducting phase III efficacy studies of a GBS vaccine candidate would require very large numbers due to the relatively low incidence of invasive GBS disease. It has therefore been proposed that alternative pathways to vaccine licensure should be explored, for example, through use of a regulatory approved correlate of protection and safety evaluation in mothers, fetuses and infants. These studies would then be followed-up with post-licensure phase IV studies in which vaccine effectiveness is evaluated.