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单剂量四价人乳头瘤病毒疫苗对年轻孕妇接种八年后人乳头瘤病毒16型和18型检测具有高效性:斐济的一项回顾性队列研究

A single dose of quadrivalent HPV vaccine is highly effective against HPV genotypes 16 and 18 detection in young pregnant women eight years following vaccination: an retrospective cohort study in Fiji.

作者信息

Reyburn Rita, Tuivaga Evelyn, Ratu Tupou, Young Seruwaia, Garland Suzanne M, Murray Gerald, Cornall Alyssa, Tabrizi Sepehr, Nguyen Cattram D, Jenkins Kylie, Tikoduadua Lisi, Kado Joseph, Kama Mike, Rafai Eric, Devi Rachel, Mulholland Kim, Fong James, Russell Fiona M

机构信息

Murdoch Children's Research Institute, Melbourne, Victoria, Australia.

Ministry of Health and Medical Services, Suva, Fiji.

出版信息

Lancet Reg Health West Pac. 2023 Jun 14;37:100798. doi: 10.1016/j.lanwpc.2023.100798. eCollection 2023 Aug.

Abstract

BACKGROUND

In 2008/9, Fiji vaccinated >30,000 girls aged 9-12 years with the quadrivalent human papillomavirus (4vHPV) vaccine coverage for at least one dose was >60% (one dose only was 14%, two dose only was 13%, three doses was 35%). We calculated vaccine effectiveness (VE) of one, two and three doses of 4vHPV against oncogenic HPV genotypes 16/18, eight years following vaccination.

METHODS

A retrospective cohort study was undertaken (2015-2019) in pregnant women ≤23 years old, eligible to receive 4vHPV in 2008/9, with confirmed vaccination status. The study was restricted to pregnant women due to the cultural sensitivity of asking about sexual behavior in Fiji. For each participant a clinician collected a questionnaire, vaginal swab and genital warts examination, a median eight (range 6-11) years post vaccination. HPV DNA was detected by molecular methods. Adjusted VE (aVE) against the detection of vaccine HPV genotypes (16/18), the comparison group of non-vaccine genotypes (31/33/35/39/45/51/52/56/58/59/66/68), and genital warts were calculated. Covariates included in the adjusted model were: age, ethnicity and smoking, according to univariate association with any HPV detection.

FINDINGS

Among 822 participants the prevalence of HPV 16/18 in the unvaccinated, one, two and three-dose groups were 13.3% (50/376), 2.5% (4/158), 0% (0/99) and 1.6% (3/189), respectively; and for the non-vaccine high-risk genotypes, the detection rate was similar across dosage groups (33.2%-40.4%, p = 0.321). The aVE against HPV 16/18 for one, two and three doses were 81% (95% CI; 48-93%), 100% (95% CI; 100-100%), and 89% (95% CI; 64-96%), respectively. Prevalence of HPV 16/18 was lower among women with longer time since vaccination.

INTERPRETATIONS

A single dose 4vHPV vaccine is highly effective against HPV genotypes 16 and 18 eight years following vaccination. Our results provide the longest duration of protection for reduced dose 4vHPV schedule in a low- or middle-income country in the Western Pacific region.

FUNDING

This study was supported by the Bill & Melinda Gates Foundation and the Department of Foreign Affairs and Trade of the Australian Government and Fiji Health Sector Support Program (FHSSP). FHSSP is implemented by Abt JTA on behalf of the Australian Government.

摘要

背景

2008年至2009年期间,斐济为超过30000名9至12岁的女孩接种了四价人乳头瘤病毒(4vHPV)疫苗,至少接种一剂的覆盖率超过60%(仅接种一剂的为14%,仅接种两剂的为13%,接种三剂的为35%)。我们计算了接种4vHPV疫苗一剂、两剂和三剂后八年,针对致癌性人乳头瘤病毒16/18型的疫苗效力(VE)。

方法

2015年至2019年对23岁及以下在2008年至2009年期间有资格接种4vHPV疫苗且接种状态得到确认的孕妇进行了一项回顾性队列研究。由于在斐济询问性行为存在文化敏感性,该研究仅限于孕妇。对于每位参与者,临床医生在接种疫苗后中位数八年(范围6至11年)收集了一份问卷、阴道拭子和生殖器疣检查。通过分子方法检测人乳头瘤病毒DNA。计算了针对疫苗型人乳头瘤病毒(16/18)检测、非疫苗型基因型(31/33/35/39/45/51/52/56/58/59/66/68)比较组以及生殖器疣的调整后疫苗效力(aVE)。调整模型中纳入的协变量有:年龄、种族和吸烟情况,依据与任何一种人乳头瘤病毒检测的单变量关联而定。

研究结果

在822名参与者中,未接种疫苗组、接种一剂组、接种两剂组和接种三剂组中16/18型人乳头瘤病毒的患病率分别为13.3%(50/376)、2.5%(4/158)、0%(0/99)和1.6%(3/189);对于非疫苗型高危基因型,各剂量组的检测率相似(33.2% - 40.4%,p = 0.321)。接种一剂、两剂和三剂疫苗针对16/18型人乳头瘤病毒的aVE分别为81%(95%置信区间;48 - 93%)、100%(95%置信区间;100 - 100%)和89%(95%置信区间;64 - 96%)。自接种疫苗后时间越长的女性,16/18型人乳头瘤病毒的患病率越低。

解读

接种一剂4vHPV疫苗在接种后八年对16型和18型人乳头瘤病毒具有高度效力。我们的研究结果为西太平洋地区低收入或中等收入国家的4vHPV减剂量接种方案提供了最长的保护期。

资金来源

本研究由比尔及梅琳达·盖茨基金会、澳大利亚政府外交与贸易部以及斐济卫生部门支持项目(FHSSP)资助。FHSSP由Abt JTA代表澳大利亚政府实施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d62a/10285272/bcd30562def5/gr1.jpg

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