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.
Bibliographical noteFunding Information:
Accepted for publication March 1, 2019. From the Paediatric Infectious Diseases Research Group, Institute of Infection & Immunity, St George’s University of London, London, United Kingdom. K.L.D. is funded by the Bill and Melinda Gates Foundation (OPP1153630, 1195841, 1189053) C.C.-A. is joint first author. K.L.D. has received funds from Pfizer to attend a meeting regarding GBS vac-cination. P.T.H. is an investigator for clinical trials done on behalf of St George’s University of London, United Kingdom, sponsored by various vac-cine manufacturers, including Novartis, Novavax, Pfizer, and GlaxoSmith-Kline. H.G.D. and C.C.A. declare no conflicts of interest. Address for correspondence: Hannah G. Davies, MBChB, Paediatric Infectious Diseases Research Group, Institute of Infection & Immunity, St George’s University of London, Jenner Wing, Level 2, Mailpoint J2C, Cranmer Ter-race, London SW17 0RE, United Kingdom. E-mail: email@example.com. Copyright 2019 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0891-3668/19/3806-0S72 DOI: 10.1097/INF.0000000000002328
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved
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