四价人乳头瘤病毒疫苗接种10年保护效果与免疫原性评价研究  

Evaluation of the 10-year protective effect and immunogenicity of quadrivalent HPV vaccination

作　　者：潘程浩 徐小倩 文天萌 王美玉 马俊飞 韩锦秀 李书华 胡尚英 乔友林[7] 赵方辉 Pan Chenghao;Xu Xiaoqian;Wen Tianmeng;Wang Meiyu;Ma Junfei;Han Jinxiu;Li Shuhua;Hu Shangying;Qiao Youlin;Zhao Fanghui(Department of Cancer Epidemiology,National Cancer Center/National Clinical Research Center for Cancer Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Clinical Epidemiology and EBM Unit,Beijing Friendship Hospital,Capital Medical University,Beijing Clinical Research Institute,Beijing 100050,China;Institute for Biological Product Control,National Institutes for Food and Drug Control,Beijing 100050,China;Xiangyuan Maternity and Child Health Service Center,Shanxi Province,Changzhi 046299,China;Wuxiang Maternity and Child Health Service Center,Changzhi 046399,China;Qinxian Maternity and Child Health Service Center,Changzhi 046499,China;Department of Population Medicine,School of Population Medicine and Public Health,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100005,China)

机构地区：[1]国家癌症中心国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院流行病学研究室,北京100021 [2]首都医科大学附属北京友谊医院北京市临床医学研究所临床流行病学与循证医学研究室,北京100050 [3]中国食品药品检定研究院生物制品检定所,北京100050 [4]山西省襄垣县妇幼保健计划生育服务中心,长治046299 [5]山西省武乡县妇幼保健计划生育服务中心,长治046399 [6]山西省沁县妇幼保健计划生育服务中心,长治046499 [7]北京协和医学院群医学及公共卫生学院,北京100005

出　　处：《中华预防医学杂志》2024年第10期1508-1513,共6页Chinese Journal of Preventive Medicine

基　　金：国家自然科学基金(82273273);美国中华医学基金会公开竞争项目(21-420)。

摘　　要：目的评估20~45岁中国女性接种四价人乳头瘤病毒(HPV)疫苗10年保护效果和免疫原性。方法于2019年10月至2020年4月对四价HPV疫苗Ⅲ期临床试验(NCT00834106)对象展开长期随访研究,进行问卷调查、静脉血采样、妇科检查、宫颈脱落细胞病理学检查并通过假病毒中和试验测定受试者血清HPV-6、11、16和18中和抗体滴度。比较不同对象宫颈脱落细胞的细胞学检查结果和血清抗体阳性率及滴度。结果共随访889名对象,对照组、疫苗接种组和补接种组分别为240、453和196名。对照组年龄为(40±7)岁,高于补接种组和疫苗接种组[分别为(38±4)和(38±6)岁](P<0.05),各组对象安全套使用情况和性生活频率差异均无统计学意义(均P>0.05)。接种组宫颈脱落细胞病理学检查异常比例为3.7%(17/453),明显低于对照组[9.6%(23/240)]和补接种组[5.6%(11/196)](P<0.05)。疫苗接种组子宫颈上皮内瘤变(CIN)1级2例,对照组CIN1级2例,CIN2级及以上3例,补接种组未发现CIN1级及以上病例。疫苗接种组和补接种组HPV-18抗体阳性率分别为35.5%(161/453)和76.0%(149/196),明显低于其他型别(P<0.05)。疫苗接种组(补接种组)与对照组中和抗体GMT比值范围为2.62~25.33(9.05~83.08)。结论中国20~45岁女性接种四价HPV疫苗10年后仍存在保护性中和抗体。ObjectiveTo evaluate the 10-year protective effect and immunogenicity of quadrivalent human papillomavirus(HPV)vaccine in Chinese women aged 20 to 45 years.MethodsFrom October 2019 to April 2020,a long-term follow-up study was conducted on the subjects of the Phase III clinical trial of the quadrivalent HPV vaccine(NCT00834106).Participants underwent a questionnaire survey,venous blood sampling,gynecological examination,cervical exfoliated cell pathology examination,and serum neutralizing antibody titers for HPV-6,11,16,and 18 were measured using a pseudovirus neutralization assay.The results of the cytological examination and the positive rate and titers of serum antibodies of different cervical exfoliated cells were compared.ResultsA total of 889 subjects were followed up,including 240 in the control group,453 in the vaccination group and 196 in the post-trial vaccination group.The age of the control group was(40±7)years old,which was higher than that of the supplementary vaccination group and the vaccination group[(38±4)and(38±6)years old,respectively](P<0.05).There were no statistically significant differences in condom use and sexual frequency among all groups(all P values>0.05).The abnormal proportion of cervical exfoliation cytopathology in the vaccination group was 3.7%(17/453),which was significantly lower than that in the control group[9.6%(23/240)]and post-trial vaccination group[5.6%(11/196)](P<0.05).There were two cases of cervical intraepithelial neoplasia(CIN)grade 1 in the vaccination group,two cases of CIN grade 1 and three cases of CIN grade 2 and above in the control group,and no CIN grade 1 and above cases in the post-trial vaccination group.The positive rate of HPV-18 antibody was 35.5%(161/453)in the vaccination group and 76.0%(149/196)in the post-trial vaccination group,which was significantly lower than that of other types(P<0.05).The neutralizing antibody GMT ratio between the vaccination group and the control group ranged from 2.62 to 25.33(9.05 to 83.08).ConclusionProtective neutrali

关 键 词：宫颈肿瘤 乳头状瘤病毒疫苗 免疫效果 随访研究 

分 类 号：R186[医药卫生—流行病学]