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Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination.人乳头瘤病毒16/18型AS04佐剂疫苗的持续疗效、免疫原性及安全性:接种疫苗后长达9.4年的长期随访研究最终分析
Hum Vaccin Immunother. 2014;10(8):2147-62. doi: 10.4161/hv.29532.
2
Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study.HPV 16/18 AS04 佐剂疫苗在 25 岁以上女性中的功效、安全性和免疫原性:3 期、双盲、随机对照 VIVIANE 研究的 4 年中期随访。
Lancet. 2014 Dec 20;384(9961):2213-27. doi: 10.1016/S0140-6736(14)60920-X. Epub 2014 Sep 1.
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Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP).人乳头瘤病毒疫苗接种:免疫实践咨询委员会(ACIP)的建议。
MMWR Recomm Rep. 2014 Aug 29;63(RR-05):1-30.
4
Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults.四价人乳头瘤病毒疫苗在 HIV 感染和 HIV 阴性青少年和年轻成人中的安全性和免疫原性。
Vaccine. 2014 Sep 29;32(43):5657-61. doi: 10.1016/j.vaccine.2014.08.011. Epub 2014 Aug 20.
5
Human papillomavirus vaccination coverage among adolescents, 2007-2013, and postlicensure vaccine safety monitoring, 2006-2014--United States.2007 - 2013年美国青少年人乳头瘤病毒疫苗接种覆盖率及2006 - 2014年疫苗上市后安全性监测
MMWR Morb Mortal Wkly Rep. 2014 Jul 25;63(29):620-4.
6
Quadrivalent human papillomavirus vaccine and the risk of venous thromboembolism.四价人乳头瘤病毒疫苗与静脉血栓栓塞风险
JAMA. 2014 Jul;312(2):187-8. doi: 10.1001/jama.2014.2198.
7
Effect on HPV vaccination in Japan resulting from news report of adverse events and suspension of governmental recommendation for HPV vaccination.因不良事件的新闻报道及政府暂停人乳头瘤病毒(HPV)疫苗接种建议而对日本HPV疫苗接种产生的影响。
Int J Clin Oncol. 2015 Jun;20(3):549-55. doi: 10.1007/s10147-014-0723-1. Epub 2014 Jul 9.
8
Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial.人乳头瘤病毒16/18 AS04佐剂疫苗在10至14岁女孩中的长期免疫原性和安全性:一项初始观察者设盲随机试验的6年开放随访
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Human papillomavirus vaccination: where are we now?人乳头瘤病毒疫苗接种:我们目前处于什么阶段?
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10
Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18-25 years: results from a randomized controlled trial.HPV-16/18 AS04佐剂疫苗在18至25岁中国健康女性中的有效性、免疫原性和安全性:一项随机对照试验的结果
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人乳头瘤病毒疫苗的安全性:综述

Safety of human papillomavirus vaccines: a review.

作者信息

Stillo Michela, Carrillo Santisteve Paloma, Lopalco Pier Luigi

机构信息

Department of Public Health and Paediatric sciences, University of Turin.

出版信息

Expert Opin Drug Saf. 2015 May;14(5):697-712. doi: 10.1517/14740338.2015.1013532. Epub 2015 Feb 18.

DOI:10.1517/14740338.2015.1013532
PMID:25689872
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4667712/
Abstract

INTRODUCTION

Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere.

AREAS COVERED

Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed.

EXPERT OPINION

Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.

摘要

引言

2006年至2009年间,两种不同的人乳头瘤病毒(HPV)疫苗获得许可使用:一种四价(qHPVv)疫苗和一种二价(bHPVv)疫苗。自2008年以来,大多数工业化国家已实施HPV疫苗接种计划。自2013年以来,HPV疫苗接种已成为66个国家国家计划的一部分,包括北美和西欧的几乎所有国家。尽管各国都做出了种种努力,但接种率仍低于预期。疫苗安全性是欧盟/欧洲经济区及其他地区HPV疫苗接种率未达预期的主要担忧之一。

涵盖领域

对二价和四价HPV疫苗在上市前和上市后阶段公布的安全性数据进行了综述。

专家意见

根据最新科学证据,两种HPV疫苗似乎都是安全的。然而,公众对不良事件(AE)的担忧和传言是提高疫苗接种率需要克服的重要障碍。对AE的被动监测是检测安全信号的重要工具,但还应辅以旨在评估所有可疑AE真正原因的活动。改进疫苗安全性监测是以科学证据为基础进行有效沟通的第一步。