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一项关于日本疫苗短缺期间 17D-204 黄热病疫苗安全性的全国前瞻性队列研究。

A nationwide prospective cohort study on safety of the 17D-204 yellow fever vaccine during a vaccine shortage in Japan.

机构信息

Disease Control and Prevention Center, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan.

Division of Quarantine and Sanitation, Chubu Airport Quarantine Office, Nagoya Quarantine Station, Nagoya 479-0881, Japan.

出版信息

J Travel Med. 2023 Apr 5;30(2). doi: 10.1093/jtm/taac070.

DOI:10.1093/jtm/taac070
PMID:35640301
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10075058/
Abstract

In response to the vaccine shortage of yellow fever vaccine (YF-VAX) due to manufacturing delays, the unapproved 17D-204 YF-VAX was used as an investigator-initiated clinical trial in Japan. The vaccine was administered to 11 279 participants in 19 YF vaccination centres in Japan, and few serious adverse events were observed.

摘要

由于黄热病疫苗(YF-VAX)的生产延迟,导致疫苗短缺,日本因此开展了一项研究者发起的临床试验,使用了未经批准的 17D-204 YF-VAX。该疫苗在日本的 19 个 YF 疫苗接种中心对 11279 名参与者进行了接种,观察到的严重不良事件很少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/907a/10075058/89f428f883ca/taac070f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/907a/10075058/89f428f883ca/taac070f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/907a/10075058/89f428f883ca/taac070f1.jpg

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本文引用的文献

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J Travel Med. 2019 Sep 2;26(6). doi: 10.1093/jtm/tay151.
2
Fractional dosing of yellow fever vaccine during shortages: perspective from Canada.黄热病疫苗短缺期间的分次给药:来自加拿大的观点
J Travel Med. 2018 Jan 1;25(1). doi: 10.1093/jtm/tay098.
3
Update: Temporary Total Depletion of U.S. Licensed Yellow Fever Vaccine for Civilian Travelers Addressed by Investigational New Drug Use of Imported Stamaril Vaccine.最新消息:通过进口Stamaril疫苗的新药研究性使用解决美国民用旅行者许可黄热病疫苗暂时全面短缺问题。
美国扩大准入研究新药方案下使用的 STAMARIL®黄热病疫苗的强化安全性监测。
J Travel Med. 2023 Nov 18;30(7). doi: 10.1093/jtm/taad037.
MMWR Morb Mortal Wkly Rep. 2017 Jul 28;66(29):780. doi: 10.15585/mmwr.mm6629a4.
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Overview of FDA's Expanded Access Program for Investigational Drugs.美国食品药品监督管理局(FDA)研究性药物扩大使用项目概述。
Ther Innov Regul Sci. 2017 Mar 1;51(2):177-179. doi: 10.1177/2168479017694850.
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Addressing a Yellow Fever Vaccine Shortage - United States, 2016-2017.应对黄热病疫苗短缺问题——美国,2016 - 2017年
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