摘要
目的在Ⅰ期临床研究中初步评价四价重组人乳头瘤病毒疫苗(HPV6/11/16/18型)(汉逊酵母)在18~45岁健康女性人群的免疫原性。方法单中心、随机、双盲、安慰剂对照,采用0、2、6月免疫程序,按照2∶1的比例随机接种实验疫苗和对照疫苗(实验组:60人,安慰剂组:30人)并采集受试者0 d、180 d及210 d血清样本,检测HPV6/11/16/18型中和抗体,观察抗体阳转率和抗体水平。结果完成2剂疫苗免疫后(180 d)和全程免疫后30 d(210 d)的抗体阳转率较为接近,各型抗体阳转率均在85%~100%之间;完成全程免疫后30 d抗体几何平均滴度(GMT)较免疫前显著提高。结论本品Ⅰ期临床研究入组的18~45岁健康女性人群接种实验疫苗后产生良好的免疫应答,可检测到明显高于首剂免疫前和安慰剂对照组的抗体水平。
Objective To make a preliminary assessment on the immunogenicity of a quadrivalence recombinant human papillomavirus(HPV)vaccine(6,11,16 and 18 types)(Hansenulapolymorpha)in healthy women aged 18-45 years in phaseⅠclinical study.Methods It was a single-center,double-blind,randomized,placebo-controlled phaseⅠclinical study.Women aged 18-45 years were randomized(2∶1)to receive HPV vaccine(n=60)or placebo control(n=30)at months 0,2 and 6.Antibodies against HPV6/11/16/18 were detected by pseudovirus-based neutralisation assay in serum samples collected at 0 d,180 d and 210 d.Seroconversion rates and geometric mean titres(GMT)of antibodies against the four types of antigens were calculated.Results Seroconversion rates of the vaccination group at 180 d(before the third dose)and 210 d(one month after the third dose)were generally similar and between 85%-100%for all types of antibodies.The GMT of antibodies at one month after the last dose improved significantly compared with those before immunization.Conclusions These results showed that the HPV vaccine had good immunogenicity in the population of healthy women aged 18-45 years.Higher antibody titers were elicited by the vaccine compare with the tites before the first dose and in the placebo control group.
作者
康赟
芦强
屈戈
张靖
赵晨燕
杜丽芳
柳军凯
刘强
聂建辉
白云骅
罗凤基
李启明
Kang Yun;Lu Qiang;Qu Ge;Zhang Jing;Zhao Chenyan;Du Lifang;Liu Junkai;Liu Qiang;Nie Jianhui;Bai Yunhua;Luo Fengji;Li Qiming(National Vaccine&Serum Institute,Beijing 101111,China;Department of Biological Products,Beijing Chaoyang District Center for Diseases Prevention and Control,Beijing 100021,China;Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China;Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中华微生物学和免疫学杂志》
CAS
CSCD
北大核心
2019年第12期916-920,共5页
Chinese Journal of Microbiology and Immunology
关键词
HPV6/11/16/18(汉逊酵母)
免疫原性
阳转率
几何平均滴度
Quadrivalence recombinant human papillomavirus vaccine(6
11
16 and 18 types)(Hansenulapolymorpha)
Immunogenicity
Seroconversion rate
Geometric mean titer
