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HPV-16/18 AS04 佐剂疫苗对低危型 HPV 类型的疗效(PATRICIA 随机试验):意外观察。

Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation.

机构信息

Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, United Kingdom.

出版信息

J Infect Dis. 2013 Nov 1;208(9):1391-6. doi: 10.1093/infdis/jit360.

DOI:10.1093/infdis/jit360
PMID:24092907
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3789574/
Abstract

BACKGROUND

Public Health England has reported a decrease of up to 20.8% in new diagnoses of external genital warts (GWs) among women aged <19 years since the national vaccination program with the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine began in 2008. A post hoc analysis of the phase III PATRICIA (PApilloma TRIal against Cancer In young Adults) trial (NCT00122681) was performed to ascertain whether protection against low-risk HPV types was apparent.

METHODS

Vaccine efficacy (VE) at 48 months was assessed against 6-month persistent infection (6MPI) with low-risk HPV types in the total vaccinated cohort (TVC) and in the TVC naive (for 25 HPV types tested) populations.

RESULTS

In the TVC naive cohort, VE against 6MPI (95% confidence interval) was 34.5% (11.3 to 51.8) for HPV-6/11, 34.9% (9.1 to 53.7) for HPV-6, 30.3% (-45.0 to 67.5) for HPV-11, and 49.5% (21.0 to 68.3) for HPV-74.

CONCLUSIONS

The HPV-16/18 AS04-adjuvanted vaccine appears to have moderate efficacy against persistent infections with a number of low-risk HPV types (HPV-6/11/74), which are responsible for the majority of external GWs, and recently, antibody and cell-mediated immune response to HPV-6/11 have been observed. These findings may help to explain the decrease in external GW diagnoses seen in England.

摘要

背景

自 2008 年英国开展 HPV-16/18 AS04 佐剂疫苗国家接种项目以来,英国公共卫生署报告称,19 岁以下女性新发外阴生殖器疣(GW)的诊断率下降了 20.8%。对 HPV-16/18 AS04 佐剂疫苗 III 期 PATRICIA(PApilloma TRIal against Cancer In young Adults)试验(NCT00122681)的事后分析旨在确定是否对低危 HPV 型具有保护作用。

方法

总接种人群(TVC)和 TVC 未接种人群(针对 25 种 HPV 型检测)中,48 个月时针对低危 HPV 型 6 个月持续性感染(6MPI)的疫苗效力(VE)。

结果

在 TVC 未接种人群中,针对 6MPI(95%置信区间)的 VE 为 HPV-6/11 为 34.5%(11.3-51.8)、HPV-6 为 34.9%(9.1-53.7)、HPV-11 为 30.3%(-45.0-67.5)和 HPV-74 为 49.5%(21.0-68.3)。

结论

HPV-16/18 AS04 佐剂疫苗似乎对多种低危 HPV 型(HPV-6/11/74)的持续性感染具有中等效力,这些 HPV 型是大多数外阴 GW 的主要病因,最近还观察到 HPV-6/11 的抗体和细胞介导免疫反应。这些发现可能有助于解释英国外阴 GW 诊断率下降的情况。

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