Cited by 105Neonatal and Maternal InfectionsBacterial Infections and VaccinesStreptococcal Infections and Treatments

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WHO consultation on group B Streptococcus vaccine development: Report from a meeting held on 27–28 April 2016

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Kobayashi, Miwako, Schrag, Stephanie J., Alderson, Mark R., Madhi, Shabir A., Baker, Carol J., Sobanjo-ter Meulen, Ajoke, Kaslow, David C., Smith, Peter G., Moorthy, Vasee S., Vekemans, Johan·2019·Vaccine

DOI 10.1016/j.vaccine.2016.12.029PMC PMC6892266

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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.

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Authors: Kobayashi, M., Schrag, S. J., Alderson, M. R., Madhi, S. A., Baker, C. J., Sobanjo-ter Meulen, A., Kaslow, D. C., Smith, P. G., Moorthy, V. S., & Vekemans, J.
Affiliations: Centers for Disease Control and Prevention (US)
Program for Appropriate Technology in Health (US)
University of the Witwatersrand (ZA)
Baylor College of Medicine (US)
London School of Hygiene & Tropical Medicine (GB)
World Health Organization (CH)
Corresponding author: Vekemans, Johan
ORCID: Kobayashi, Miwako
Schrag, Stephanie J.
Alderson, Mark R.
Madhi, Shabir A.
Kaslow, David C.
Smith, Peter G.
Moorthy, Vasee S.
Vekemans, Johan
Venue: Vaccine
Publisher: Elsevier BV
Published: 2019-11
Volume: 37
Issue: 50
Pages: 7307-7314
ISSN: 0264-410X (ISSN-L)
DOI: 10.1016/j.vaccine.2016.12.029
PMC: PMC6892266
OpenAlex: W2561215256
Cited by: 105
References: 55
Citations by year: 2026: 6 · 2025: 8 · 2024: 6 · 2023: 9 · 2022: 12 · 2021: 16 · 2020: 11 · 2019: 11
FWCI: 1.79
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by/4.0/ (vor)
Locations: Vaccine (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Lincoln (University of Nebraska) (submittedVersion, cc-by)
Funders: Novartis/GSK
Bill & Melinda Gates Foundation (OPP1134011)
Topics: Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal and Maternal Infections
Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Health Sciences › Medicine › Infectious Diseases › Streptococcal Infections and Treatments
Keywords: Streptococcus agalactiae, maternal immunization, intrapartum antibiotic prophylaxis, neonatal sepsis, neonatal meningitis, stillbirth, transplacental antibody transfer, serotype distribution, disease burden, correlates of protection, antibody assays, vaccine licensure, low- and middle-income countries
MeSH terms: Animals, Clinical Trials as Topic, Female, Humans, Pregnancy, Pregnancy Complications, Infectious, Streptococcal Infections, Streptococcus agalactiae, Vaccination, World Health Organization, Infectious Disease Transmission, Vertical, Streptococcal Vaccines, Stillbirth

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WHO consultation on group B Streptococcus vaccine development: Report from a meeting held on 27–28 April 2016

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