title: WHO consultation on group B Streptococcus vaccine development: Report from a meeting held on 27-28 April 2016.
abstract: Globally, group B Streptococcus (GBS) remains a leading cause of sepsis and meningitis in infants in the first 90days of life. Intrapartum antibiotic prophylaxis (IAP) for women at increased risk of transmitting GBS to their newborns has been effective in reducing part, but not all, of the GBS disease burden in many high income countries (HICs). In low- and middle-income countries (LMICs), IAP use is low. Immunization of pregnant women with a GBS vaccine represents an alternative strategy to protecting newborns and young infants, through transplacental antibody transfer and potentially by reducing new vaginal colonization. This vaccination strategy was first suggested in the 1970s and several potential GBS vaccines have completed phase I/II clinical trials. During the 2015 WHO Product Development for Vaccines Advisory Committee meeting, GBS was identified as a high priority for the development of a vaccine for maternal immunization because of the major public health burden posed by GBS in LMICs, and the high technical feasibility for successful development. Following this meeting, the first WHO technical consultation on GBS vaccines was held on the 27th and 28th of April 2016, to consider development pathways for such vaccines, focused on their potential role in reducing newborn and young infant deaths and possibly stillbirths in LMICs. Discussion topics included: (1) pathophysiology of disease; (2) current gaps in the knowledge of global disease burden and serotype distribution; (3) vaccine candidates under development; (4) design considerations for phase III trials; and (5) pathways to licensure, policy recommendations and use. Efforts to address gaps identified in each of these areas are needed to establish the public health need for, the development and deployment of, efficacious GBS vaccines. In particular, more work is required to understand the global disease burden of GBS-associated stillbirths, and to develop quality-assured standardized antibody assays to identify correlates of protection.
authors.affiliation: National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30329-4027, USA; Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
authors.forename: Miwako
authors.initials: M
authors.lastname: Kobayashi
authors.affiliation: National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30329-4027, USA.
authors.forename: Stephanie J
authors.initials: SJ
authors.lastname: Schrag
authors.affiliation: Center for Vaccine Innovation and Access, PATH, Seattle, WA 98121, USA.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Alderson
authors.affiliation: Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, and Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Shabir A
authors.initials: SA
authors.lastname: Madhi
authors.affiliation: Department of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX 77030, USA.
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Baker
authors.affiliation: Bill & Melinda Gates Foundation, Seattle, WA 98109, USA.
authors.forename: Ajoke
authors.initials: A
authors.lastname: Sobanjo-Ter Meulen
authors.affiliation: Center for Vaccine Innovation and Access, PATH, Seattle, WA 98121, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Kaslow
authors.affiliation: MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Smith
authors.affiliation: Initiative for Vaccine Research, World Health Organization, CH-1211 Geneva 27, Switzerland.
authors.forename: Vasee S
authors.initials: VS
authors.lastname: Moorthy
authors.affiliation: Initiative for Vaccine Research, World Health Organization, CH-1211 Geneva 27, Switzerland. Electronic address: vekemansj@who.int.
authors.forename: Johan
authors.initials: J
authors.lastname: Vekemans
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000276:immunology / Q000382:microbiology; D050497:Stillbirth; D013290:Streptococcal Infections / Q000276:immunology* / Q000382:microbiology; D022541:Streptococcal Vaccines / Q000276:immunology*; D013292:Streptococcus agalactiae / Q000254:growth & development*; D014611:Vaccination / Q000379:methods; D014944:World Health Organization
chemical_list: D022541:Streptococcal Vaccines
keywords: Group B Streptococcus; Maternal vaccination; Phase III trial; Vaccine licensure