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 |
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| Institution: | 1. Initiative for Vaccine Research, World Health Organization, 20 Av Appia, 1202 Geneva, Switzerland;2. Joint Committee on Vaccination and Immunisation, Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, UK;3. Division of Pediatric Infectious Diseases, University of Texas McGovern Medical School., 6431 Fannin Street, MSB 3.126, Houston, TX 77030, USA;4. Institute of Child Health, University College London, 30 Guilford St, London WC1N 1EH, UK;5. Institute of Infection and Immunity, St George’s University of London, Cranmer Terrace, London SW17 0RE, UK;6. Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, 2193 Johannesburg, South Africa;7. Statistics Unit, Public Health England, 61 Colindale Av., London NW9 5EQ, UK;8. Oxford Vaccine Group, Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford OX3 9DU, UK;9. The Child Health Research Foundation at the Bangladesh Institute of Child Health, Sher-E-Banglanagar, Dhaka Shishu Hospital, Dhaka 1207, Bangladesh;10. Respiratory Diseases Branch, Division of Bacterial Diseases at the Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta 30333, USA;11. Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK;12. PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA |
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| 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. |
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| Keywords: | Group B Streptococcus Vaccines Correlates of protection Maternal immunization Neonatal sepsis |
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