四价人乳头瘤病毒疫苗安全性概述：2006年至2015年
An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015.
作者信息
Vichnin Michelle, Bonanni Paolo, Klein Nicola P, Garland Suzanne M, Block Stan L, Kjaer Susanne K, Sings Heather L, Perez Gonzalo, Haupt Richard M, Saah Alfred J, Lievano Fabio, Velicer Christine, Drury Rosybel, Kuter Barbara J
机构信息
From the *Merck & Co., Inc., Kenilworth, New Jersey; †University of Florence, Florence, Italy; ‡Kaiser Permanente Vaccine Study Center, Oakland, California; §The Royal Women's' Hospital, Murdoch Childrens Research Institute, University of Melbourne, Parkville, Victoria, Australia; ¶Kentucky Pediatric Research, Inc., Bardstown, Kentucky; ‖Danish Cancer Society Research Center, Copenhagen, Denmark; **Department of Gynaecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; ††Universidad del Rosario, Bogota, Colombia; and ‡‡Sanofi Pasteur MSD, Lyon, France.
出版信息
Pediatr Infect Dis J. 2015 Sep;34(9):983-91. doi: 10.1097/INF.0000000000000793.
BACKGROUND
A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/11/16/18. Across 7 phase 3 clinical trials involving more than 29,000 males and females ages 9-45 years, vaccination was generally well tolerated. Because of its expected public health benefit in reducing cervical cancer and other HPV-related diseases, the vaccine has been implemented in the national vaccination programs of several countries, with over 178 million doses distributed worldwide.
METHODS
Extensive efforts to assess the safety of the vaccine in routine practice have been conducted over the past 9 years since licensure, including more than 15 studies in more than 1 million preadolescents, adolescents and adults from various countries. Most have been performed in the general population although there have been some in special populations (pregnant women, HIV-infected individuals and those with systemic lupus erythematosus).
RESULTS
We present a summary of the published, postlicensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the postlicensure setting. Serious adverse events, such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates.
CONCLUSIONS
These results, along with the safety data from the prelicensure clinical trials, confirm that the HPV4 vaccine has a favorable safety profile. Key policy, medical and regulatory organizations around the world have independently reviewed these data and continue to recommend routine HPV vaccination.
背景
四价人乳头瘤病毒（HPV4）6/11/16/18型疫苗（佳达修/希瑞适®）已在世界许多国家获得许可，用于预防宫颈癌、外阴癌、阴道癌和肛门癌及其癌前病变，以及与HPV 6/11/16/18型有因果关系的外生殖器疣。在涉及超过29000名9至45岁男性和女性的7项3期临床试验中，疫苗总体耐受性良好。由于其在降低宫颈癌和其他HPV相关疾病方面预期的公共卫生效益，该疫苗已在多个国家的国家疫苗接种计划中实施，全球已分发超过1.78亿剂。
方法
自该疫苗获得许可以来的9年里，人们为评估其在常规使用中的安全性付出了巨大努力，包括对来自不同国家的100多万名青春期前儿童、青少年和成年人进行了15项以上的研究。大多数研究是在普通人群中进行的，不过也有一些是针对特殊人群（孕妇、艾滋病毒感染者和系统性红斑狼疮患者）开展的。
结果
我们总结了主动监测和被动监测中已发表的、疫苗获批后的安全性数据。在疫苗获批后的情况下，只有晕厥以及可能的皮肤感染与接种疫苗有关。对严重不良事件，如不良妊娠结局、自身免疫性疾病（包括格林-巴利综合征和多发性硬化症）、过敏反应、静脉血栓栓塞和中风进行了广泛研究，结果发现这些事件的发生率与背景发生率相比没有增加。
结论
这些结果，连同疫苗获批前临床试验的安全性数据，证实HPV4疫苗具有良好的安全性。世界各地的主要政策、医学和监管组织已独立审查了这些数据，并继续建议进行常规HPV疫苗接种。
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