摘要
目的评价一种新型双价人乳头瘤病毒(HPV)疫苗(大肠杆菌)的有效性。方法采用多中心、随机、双盲设计,自2012年11月至2013年4月在中国5个地区入组18~45岁健康女性,按年龄分层(18~26岁组、27~45岁组)后进行区组(12个疫苗编号为一区组)随机,按1∶1比例分配至研究组(双价HPV疫苗)或对照组(戊型肝炎疫苗),按照0、1、6月三针免疫程序接种。主要终点为分析疫苗对HPV16和(或)HPV18相关的高级别生殖器癌前病变和HPV持续感染(6个月以上)。结果共入组7 372名女性,其中研究组3 689人,对照组3 683人,平均随访3.3年。在符合方案人群中,对于预防HPV16和(或)HPV18相关的高级别宫颈上皮内病变、原位腺癌和宫颈癌和HPV持续感染的有效性分别为100%(95%CI:55.6%~100%)和97.8%(95%CI:87.1%~99.9%)。疫苗的安全性良好(单独著文报道)。结论双价人乳头瘤病毒疫苗(大肠杆菌)能够有效预防HPV16和(或)HPV18相关的高级别生殖器癌前病变和HPV持续感染。
Objective To evaluate the efficacy of a novel Escherichia coli-produced bivalent HPV16/18 vaccine. Methods A multicenter, randomized, double-blind trial was conducted in five sites started from November 2012 to April 2013 in China. In total, eligible women aged 18~45 years were age-stratified(into two groups:18~26 and 27~45 years) and randomly assigned(1∶1) according to a permuted block randomization list(with 12 codes per block) to receive three doses of the test or control(hepatitis E) vaccine at months 0, 1, and 6. The primary endpoints included high-grade genital lesions and persistent infection(over 6 months) associated with HPV16/18. Results Totally 7 372 healthy women were randomly assigned to the test group(3 689) and placebo group(3 683), and were followed for an average of 3.3 years. In the per-protocol cohort, the efficacies against high-grade genital lesions and persistent infection were 100.0%(95% confidence interval=55.6% to 100.0%, and 97.8%(95% confidence interval=87.1% to 99.9%), respectively. The vaccine was well tolerated. Conclusions The E. coli-produced HPV16/18 vaccine is well tolerated and highly efficacious against HPV16/18–associated high-grade genital lesions and persistent infection in women.
作者
乔友林
吴婷
李荣成
胡月梅
魏丽惠
李长贵
陈汶
黄守杰
赵方辉
黎明强
潘秦镜
张询
李晴
洪颖
赵超
章文华
苏迎盈
王军志
朱凤才
李少伟
潘晖榕
李益民
张军
夏宁邵
QIAO Youlin;WU Ting;LI Rongcheng;HU Yuemei;WEI Lihui;LI Changgui;CHEN Wen;HUANG Shoujie;ZHAO Fanghui;LI Mingqiang;PAN Qinjing;ZHANG Xun;LI Qing;HONG Ying;ZHAO Chao;ZHANG Wenhua;SU Yingying;WANG Junzhi;ZHU Fengcai;LI Shaowei;PAN Huirong;LI Yimin;ZHANG Jun;XIA Ningshao(Department of Cancer Epidemiology,Cancer Hospital Chinese Academy of Medical Sciences,100021,China)
出处
《中国妇产科临床杂志》
CSCD
北大核心
2020年第6期581-584,共4页
Chinese Journal of Clinical Obstetrics and Gynecology
基金
中国国家高技术研究发展863计划(2012AA02A408)
中国国家科技重大专项“重大新药创制”项目(2018ZX09308010和2012ZX09101316)