WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23-24 March 2015.
WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23-24 March 2015.
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DOI：
10.1016/j.vaccine.2015.05.093
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发表时间：
2016-01-04
期刊：
影响因子：
5.5
通讯作者：
WHO RSV Vaccine Consultation Expert Group
中科院分区：
文献类型：
--
作者：
Modjarrad K;Giersing B;Kaslow DC;Smith PG;Moorthy VS;WHO RSV Vaccine Consultation Expert Group
呼吸道合胞病毒（RSV）是全球新生儿和婴儿下呼吸道感染的常见原因。尽管存在疾病负担，但安全有效的 RSV 疫苗仍然难以实现。近年来，随着对 RSV 生物学的了解的加深和免疫原设计的创新，多种候选疫苗已进入临床开发渠道。鉴于临床试验中的疫苗数量不断增加、测试速度很快，以及 RSV 疫苗在未来 5-10 年内进入商业市场的可能性，在大规模功效试验开始之前，现在需要就临床开发途径和许可途径达成共识和指导。为实现这一目标，世界卫生组织于2015年3月23日至24日在瑞士日内瓦召开了15年来首次RSV疫苗磋商会。会议的主要目标是为疫苗试验的临床终点和开发途径提供指导，重点关注低收入和中等收入国家的考虑。会议与会者就 RSV 疾病候选病例定义、临床疗效终点考虑因素以及孕产妇和儿童群体主动和被动免疫试验的临床开发路径达成共识。本次会议的战略重点是制定供全球使用的高质量、安全和有效的RSV预防干预措施，包括：（1）孕产妇/被动免疫，预防6个月以下婴儿的RSV疾病； (2) 一旦母体免疫提供的保护作用减弱，儿科免疫可预防婴幼儿RSV疾病。
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.
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影响因子：
3.7
作者：
Bloom-Feshbach K;Alonso WJ;Charu V;Tamerius J;Simonsen L;Miller MA;Viboud C
通讯作者：
Viboud C
影响因子：
6.4
作者：
Meng J;Lee S;Hotard AL;Moore ML
通讯作者：
Moore ML
DOI：
10.1164/rccm.201405-0901pp
发表时间：
2015-01-01
影响因子：
24.7
作者：
Feldman, Amy S.;He, Yuan;Hartert, Tina V.
通讯作者：
Hartert, Tina V.
影响因子：
3.7
作者：
Malkin E;Yogev R;Abughali N;Sliman J;Wang CK;Zuo F;Yang CF;Eickhoff M;Esser MT;Tang RS;Dubovsky F
通讯作者：
Dubovsky F
DOI：
10.1126/science.1234914
发表时间：
2013-05-31
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
McLellan JS;Chen M;Leung S;Graepel KW;Du X;Yang Y;Zhou T;Baxa U;Yasuda E;Beaumont T;Kumar A;Modjarrad K;Zheng Z;Zhao M;Xia N;Kwong PD;Graham BS
通讯作者：
Graham BS