title: WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23-24 March 2015.
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.
authors.affiliation: Initiative for Vaccine Research, World Health Organization, CH-1211 Geneva 27, Switzerland; U.S Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
authors.forename: Kayvon
authors.initials: K
authors.lastname: Modjarrad
authors.affiliation: Initiative for Vaccine Research, World Health Organization, CH-1211 Geneva 27, Switzerland.
authors.forename: Birgitte
authors.initials: B
authors.lastname: Giersing
authors.affiliation: PATH, Seattle, WA 98109, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Kaslow
authors.affiliation: London School of Hygiene and Tropical Medicine, London WC1E7HT, UK.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Smith
authors.affiliation: Initiative for Vaccine Research, World Health Organization, CH-1211 Geneva 27, Switzerland. Electronic address: moorthyv@who.int.
authors.forename: Vasee S
authors.initials: VS
authors.lastname: Moorthy
mesh_terms: D002986:Clinical Trials as Topic; D055808:Drug Discovery; D017408:Guidelines as Topic; D006801:Humans; D007114:Immunization / Q000379:methods*; D018357:Respiratory Syncytial Virus Infections / Q000517:prevention & control*; D022261:Respiratory Syncytial Virus Vaccines / Q000276:immunology* / Q000302:isolation & purification*; D014944:World Health Organization
chemical_list: D022261:Respiratory Syncytial Virus Vaccines
keywords: Clinical development; Respiratory syncytial virus; Vaccine