Elsevier

Vaccine

Volume 34, Issue 2, 4 January 2016, Pages 190-197
Vaccine

WHO report
WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23–24 March 2015

https://doi.org/10.1016/j.vaccine.2015.05.093Get rights and content
Under a Creative Commons license
open access

Abstract

Respiratory syncytial virus (RSV) is a globally prevalent cause of lower respiratory infection in neonates and infants. Despite its disease burden, a safe and effective RSV vaccine has remained elusive. In recent years, improved understanding of RSV biology and innovations in immunogen design has resulted in the advancement of multiple vaccine candidates into the clinical development pipeline. Given the growing number of vaccines in clinical trials, the rapid pace at which they are being tested, and the likelihood that an RSV vaccine will reach the commercial market in the next 5–10 years, consensus and guidance on clinical development pathways and licensure routes are needed now, before large-scale efficacy trials commence. In pursuit of this aim, the World Health Organization convened the first RSV vaccine consultation in 15 years on the 23rd and 24th of March, 2015 in Geneva, Switzerland. The meeting's primary objective was to provide guidance on clinical endpoints and development pathways for vaccine trials with a focus on considerations of low- and middle-income countries. Meeting participants reached consensus on candidate case definitions for RSV disease, considerations for clinical efficacy endpoints, and the clinical development pathway for active and passive immunization trials in maternal and pediatric populations. The strategic focus of this meeting was on the development of high quality, safe and efficacious RSV preventive interventions for global use and included: (1) maternal/passive immunization to prevent RSV disease in infants less than 6 months; (2) pediatric immunization to prevent RSV disease in infants and young children once protection afforded by maternal immunization wanes.

Keywords

Respiratory syncytial virus
Vaccine
Clinical development

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1

WHO RSV Vaccine Consultation Expert Group: Narendra Kumar Arora (The INCLEN Trust International, New Delhi, India). Louis Bont (University Medical Center, Utrecht, The Netherlands). Harry Campbell (Centre for Global Health Research, Edinburgh, UK). Peter Collins (National Institutes of Health, Bethesda, MD, USA). Janet Englund (University of Washington, Seattle, WA, USA). Barney S. Graham (National Institutes of Health, Bethesda, MD, USA). Deborah Higgins (PATH Seattle, WA, USA). Ruth Karron (Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA). Keith Klugman (The Bill & Melinda Gates Foundation, Seattle, WA, USA). Ivana Knezevic (World Health Organization, CH-1211 Geneva 27, Switzerland). Shabir A. Madhi (National Institute for Communicable Diseases, Johannesburg, South Africa). Harish Nair (Centre for Global Health Research, Edinburgh, UK). Patricia Njuguna (KEMRI Wellcome Trust, Kilifi, Kenya). James Nokes (KEMRI Wellcome Trust, Kilifi, Kenya; Warwick University, Coventry, UK). Fernando Polack (Fundación INFANT, Buenos Aires, Argentina). Eric A.F. Simoes (University of Colorado Health Sciences Center, Denver, CO, USA). Niteen Wairagkar (The Bill & Melinda Gates Foundation, Seattle, WA, USA). Tiequn Zhou (World Health Organization, CH-1211 Geneva 27, Switzerland).