WHO RSV Vaccine Consultation Expert Group (Including: Modjarrad, Kayvon, Giersing, Birgitte, Kaslow, David C., Smith, Peter G. and Moorthy, Vasee S.). (2016) WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23–24 March 2015. Vaccine, 34 (2). pp. 190-197. doi:10.1016/j.vaccine.2015.05.093

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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.

Item Type:	Journal Article
Subjects:	R Medicine > RM Therapeutics. Pharmacology
Divisions:	Faculty of Science > Life Sciences (2010- )
Library of Congress Subject Headings (LCSH):	Drug development, Respiratory syncytial virus, Vaccines, Virus diseases
Journal or Publication Title:	Vaccine
Publisher:	Elsevier Ltd.
ISSN:	0264-410X
Official Date:	January 2016
Dates:	Date Event January 2016 Published 20 June 2015 Available 29 May 2015 Accepted 22 May 2015 Submitted
Volume:	34
Number:	2
Page Range:	pp. 190-197
DOI:	10.1016/j.vaccine.2015.05.093
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	Bill & Melinda Gates Foundation
Contributors:	Contribution Name Contributor ID Expert Nokes, D. James 35965

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