The role of immune correlates of protection on the pathway to licensure, policy decision and use of group B Streptococcus vaccines for maternal immunization: considerations from World Health Organization consultations.

Abstract

The development of a group B Streptococcus (GBS) vaccine for maternal immunization constitutes a global public health priority, to prevent GBS-associated early life invasive disease, stillbirth, premature birth, maternal sepsis, adverse neurodevelopmental consequences, and to reduce perinatal antibiotic use. Sample size requirements for the conduct of a randomized placebo-controlled trial to assess vaccine efficacy against the most relevant clinical endpoints, under conditions of appropriate ethical standards of care, constitute a significant obstacle on the pathway to vaccine availability. Alternatively, indirect evidence of protection based on immunologic data from vaccine and sero-epidemiological studies, complemented by data from opsonophagocytic in vitro assays and animal models, could be considered as pivotal data for licensure, with subsequent confirmation of effectiveness against disease outcomes in post-licensure evaluations. Based on discussions initiated by the World Health Organization we present key considerations about the potential role of correlates of protection towards an accelerated pathway for GBS vaccine licensure and wide scale use. Priority activities to support progress to regulatory and policy decision are outlined.

• Authors: Johan Vekemans, Jonathan Crofts, Carol J Baker, David Goldblatt, Paul T Heath, Shabir A Madhi, Kirsty Le Doare, Nick Andrews, Andrew J Pollard, Samir K Saha, Stephanie J Schrag, Peter G Smith, David C Kaslow
• Journal: Vaccine (Vaccine) Vol. 37 Issue 24 Pg. 3190-3198 (05 27 2019) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 31031031 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
• Copyright: Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Streptococcal Vaccines

Topics

• Cost-Benefit Analysis
• Drug Approval
• Female
• Humans
• Infant, Newborn
• Infant, Newborn, Diseases (prevention & control)
• Maternal Health
• Pregnancy
• Pregnancy Complications, Infectious (prevention & control)
• Premature Birth (prevention & control)
• Stillbirth
• Streptococcal Infections (prevention & control, transmission)
• Streptococcal Vaccines (immunology)
• Streptococcus agalactiae
• Vaccination (legislation & jurisprudence)
• World Health Organization