Group BStreptococcusvaccine development: present status and future considerations, with emphasis on perspectives for low and middle income countries.
Globally, group BStreptococcus(GBS) remains the leading cause of sepsis and meningitis in young infants, with its greatest burden in the first 90 days of life. Intrapartum antibiotic prophylaxis (IAP) for women at risk of transmitting GBS to their newborns has been effective in reducing, but not eliminating, the young infant GBS disease burden in many high income countries. However, identification of women at risk and administration of IAP is very difficult in many low and middle income country (LMIC) settings, and is not possible for home deliveries. Immunization of pregnant women with a GBS vaccine represents an alternate pathway to protecting newborns from GBS disease, through the transplacental antibody transfer to the fetus in utero. This approach to prevent GBS disease in young infants is currently under development, and is approaching late stage clinical evaluation. This manuscript includes a review of the natural history of the disease, global disease burden estimates, diagnosis and existing control options in different settings, the biological rationale for a vaccine including previous supportive studies, analysis of current candidates in development, possible correlates of protection and current status of immunogenicity assays. Future potential vaccine development pathways to licensure and use in LMICs, trial design and implementation options are discussed, with the objective to provide a basis for reflection, rather than recommendations.
National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, USA; Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, USA.
Miwako
M
Kobayashi
Initiative for Vaccine Research, World Health Organization, Geneva, Switzerland.
Johan
J
Vekemans
Department of Pediatrics, Baylor College of Medicine, Houston, USA; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, USA; Center for Vaccine Awareness and Research, Texas Children's Hospital, Houston, USA.
Carol J
CJ
Baker
Departments of Pediatrics and Microbiology, New York University School of Medicine, New York, USA.
Adam J
AJ
Ratner
Centre for International Child Health, Imperial College, London, UK.
Kirsty
K
Le Doare
National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, USA.
Stephanie J
SJ
Schrag
Group B Streptococcus; low- and middle-income countries; maternal vaccination; neonatal sepsis; phase III trial; vaccine development