四价人乳头瘤病毒疫苗在中国大陆女性中的安全性:一项随访90个月的随机、双盲、安慰剂对照研究  

Safety of a quadrivalent human papillomavirus vaccine in a randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up

作　　者：陈汶[1] 赵昀[2] 谢幸[3] 刘继红[4] 李静然[2] 赵超[2] 王少明[1] 魏丽惠[2] 乔友林[1] CHEN Wen;ZHAO Yun;XIE Xing;LIU Jihong;LI Jingran;ZHAO Chao;WANG Shaoming;WEI Lihui;QIAO Youlin(Department of Cancer Epidemiology,Cancer Hospital Chinese Academy of Medical Sciences,Beijing 100021,China)

机构地区：[1]中国医学科学院肿瘤医院,100021 [2]北京大学人民医院 [3]浙江大学医学院附属妇产科医院 [4]中山大学附属肿瘤医院

出　　处：《中国妇产科临床杂志》2020年第6期585-588,共4页Chinese Journal of Clinical Obstetrics and Gynecology

摘　　要：目的探讨中国大陆20~45岁女性接种四价人乳头瘤病毒(HPV6/11/16/18)疫苗随访90个月的安全性。方法受试者3 006名按1:1随机分组,分别接种三剂四价HPV疫苗或安慰剂(第1天、第2个月和第6个月)。收集每剂接种后15 d内接种部位及全身不良事件。在整个研究期间收集严重不良事件、妊娠结局、新发异常疾病及胎儿/婴儿严重不良事件。结果在3 006名受试者中,926名(61.8%)四价HPV疫苗受试者和856名(57.1%)安慰剂受试者报告了不良事件。4名受试者(每组各2名)因为发生了疑似与接种相关的不良事件而退出研究。接种后15 d内,四价HPV疫苗受试者接种部位不良事件的发生率更高(37.6%vs 27.8%,P <0.001),但全身不良事件的发生率与安慰剂组相当(46.8%vs 45.1%,P>0.05)。疫苗组严重不良事件38例,安慰剂组43例。尚未发现严重不良事件与四价HPV疫苗相关。两组的妊娠结局及胎儿/婴儿严重不良事件发生率相当。结论在中国大陆20~45岁女性中,四价HPV疫苗耐受性良好,其安全性结果与全球临床试验及安全性监测研究的结果一致。Objective To investigate the safety of Chinese women aged 20~45 years after receiving quadrivalent HPV(q HPV)vaccine for 90 months. Methods 3 006 participants were randomized 1:1 to receive three doses of qHPV vaccine or placebo(Day 1, Month 2, and Month 6). Efficacy outcomes are reported elsewhere. Injection-site and systemic adverse events(AEs) were collected using vaccination report cards(VRCs) for 15 days following each vaccination. Serious AEs(SAEs), pregnancy outcomes, new medical conditions, and fetal/infant SAEs were collected during the entire study. Results Of 3 006 participants randomized, AEs were reported by 926(61.8%) qHPV vaccine recipients and 856(57.1%) placebo recipients over the entire study. Four participants(two in each group) discontinued the study vaccination due to AEs that were considered vaccination-related. Within 15 days following any vaccination, injection-site AEs prompted for on the VRC were more frequent among qHPV vaccine recipients(37.6% vs 27.8%, P < 0.01), and systemic AEs prompted for on the VRC were similar in frequency between qHPV vaccine and placebo groups(46.8% vs 45.1%, P > 0.05). Thirty-eight and 43 participants reported SAEs in qHPV vaccine and placebo groups, respectively. No SAE was considered qHPV vaccine-related. Pregnancy outcomes, fetal/infant SAEs, and new medical conditions were generally similar in frequency between the qHPV vaccine and placebo groups. Conclusion The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20–45 years of age, consistent with the findings from global clinical trials and safety surveillance studies.

关 键 词：四价HPV疫苗 安全性 中国 随机对照临床试验 

分 类 号：R737.33[医药卫生—肿瘤]