Cancer Epidemiology Unit, Aviano National Cancer Institute IRCCS, Via Franco Gallini 2, 33081 Aviano (PN), Italy.
International Agency for Research on Cancer, 150 cours Albert Thomas, 69372 Lyon Cedex 08, France.
Vaccine. 2018 Aug 6;36(32 Pt A):4816-4822. doi: 10.1016/j.vaccine.2018.02.002. Epub 2018 Mar 21.
Based on existing evidence for efficacy, savings, and advantages in delivery, some countries may elect to pilot or roll out single-dose human papillomavirus (HPV) vaccination (instead of, or in combination with, two-dose) in advance of a WHO policy decision. Accelerated evidence of population-based effectiveness (hereafter referred to as overall effectiveness, OE) of one-dose vaccine programs could be gained through regular surveys of HPV prevalence in young women before and after vaccination introduction. In order to offer the earliest information on OE, one-dose HPV vaccination should target one or more birth cohorts as close as possible to the age when sexual activity most often starts in a given population. A catch-up one-dose vaccination program of girls up to 18 years of age who would have been too old to profit from the introduction of a routine HPV vaccination program in preadolescents would minimize the interval between vaccination and the possibility to monitor vaccination impact in young women. In addition, catch-up is especially desirable in low- and middle-income countries with little access to screening as "missed" cohorts may face high risk of cervical cancer death. HPV prevalence should be firstly monitored in age groups of women who may already be sexually active but still reluctant to admit it and to accept vaginal examination for the collection of cervical cells. Hence, HPV testing from urine samples, for which good concordance with cervical cells has been proven, offers a feasible approach to assess periodically vaccine OE in representative samples of 17-20 year-old women. This type of observational study would greatly benefit from the presence of a population census and the creation of a vaccination registry. A real-world demonstration of OE of the new schedule would complement the findings of ongoing clinical trials and immunogenicity studies on the efficacy of single-dose HPV vaccination.
基于现有疗效、节省成本和接种优势的证据，一些国家可能会选择在世界卫生组织做出政策决定之前，试行或推出单剂量人乳头瘤病毒（HPV）疫苗接种（替代或结合两剂量接种）。通过在疫苗接种引入前后定期调查年轻女性 HPV 流行率，可以获得单剂量疫苗接种计划对人群的加速有效性（以下简称总体有效性，OE）证据。为了尽早提供 OE 的信息，单剂量 HPV 疫苗接种应针对尽可能接近特定人群中性行为最常开始的年龄的一个或多个出生队列。对年龄在 18 岁以下的女孩进行单剂量补种接种，这些女孩已经超过了在青春期前引入常规 HPV 疫苗接种计划的受益年龄，这将最大限度地缩短疫苗接种和监测年轻女性疫苗接种效果的可能性之间的时间间隔。此外，在获得筛查机会较少的低收入和中等收入国家中，补种尤其可取，因为“错过”的队列可能面临宫颈癌死亡的高风险。HPV 流行率应首先在可能已经有性行为但仍不愿意承认并接受阴道检查以收集宫颈细胞的女性年龄组中进行监测。因此，HPV 尿液检测（已证明与宫颈细胞具有良好的一致性）为定期评估代表 17-20 岁女性的疫苗 OE 提供了一种可行的方法。这种类型的观察性研究将极大地受益于人口普查的存在和疫苗接种登记的建立。对新时间表 OE 的真实世界演示将补充正在进行的临床试验和关于单剂量 HPV 疫苗接种功效的免疫原性研究的结果。
