Lehtinen Matti, Apter Dan, Baussano Iacopo, Eriksson Tiina, Natunen Kari, Paavonen Jorma, Vänskä Simopekka, Bi Dan, David Marie-Pierre, Datta Sanjoy, Struyf Frank, Jenkins David, Pukkala Eero, Garnett Geoff, Dubin Gary
University of Tampere, Tampere, Finland.
Family Federation of Finland, Helsinki and Oulu, Finland.
Vaccine. 2015 Mar 3;33(10):1284-90. doi: 10.1016/j.vaccine.2014.12.019. Epub 2015 Jan 12.
High-risk human papillomaviruses (hrHPV) cause anogenital and oropharyngeal cancers. HPV-16/18 virus-like particle vaccine formulated with an AS04 adjuvant is very efficacious against hrHPV associated precancers but the herd effects of different vaccination scenarios are not known. Our cluster randomized trial (NCT00534638) assesses the overall and herd effects of vaccinating girls vs. girls and boys. In two school-years (2007-2008 and 2008-2009) we invited 80,272 1992-1995 born early adolescents to a CRT in 33 communities a priori stratified by low, intermediate and high HPV-16/18 seroprevalence. In 11 Arm A communities 90% of participating girls and boys were assigned to receive HPV-16/18 vaccine, in 11 Arm B communities 90% of girls were assigned to receive HPV-16/18 vaccine - boys were assigned to receive hepatitis B-virus (HBV) vaccine, and in 11 Arm C communities all were assigned to receive HBV-vaccine. Prevalence of HPV in vaccinated and unvaccinated girls is studied at age 18.5 years. Recruitment resulted in equal enrolment of four birth cohorts (born 1992-1995) comprising altogether 32,175 (40% response) early adolescents: 20,514 girls (50.5-53.0% response by arm) and 11,661 boys (21.9-31.6%% response by arm). At the age of 15 years, 79.3% of the vaccinees completed a questionnaire. Among them >98% were living at, and during the week-ends 1.3-1.6% stayed outside, the study site communities. Smoking habit and alcohol consumption were similar in the different trial arms, also mean-age of menarche (12.4 years) and 1st ejaculation (12.6 years), and sexual behaviour (among those <25%, who had had sexual debut) did not differ by arm: mean-age at the sexual debut 14.3 and 14.4 in girls and boys, and proportions of those with multiple (≥5) life-time sexual partners (6.5-7.5%) at the age of 15 years. Uniform residential, life-style and sexual behaviour characteristics indicate successful randomization/enrolment of the CRT. Our CRT will verify modelled predictions on up to 31% herd effect of vaccinating both girls and boys with moderate vaccine coverage - quantifying overall effectiveness of different strategies which will soon guide how to implement HPV vaccination.
高危型人乳头瘤病毒（hrHPV）可引发肛门生殖器癌和口咽癌。含AS04佐剂的HPV-16/18病毒样颗粒疫苗对hrHPV相关的癌前病变非常有效，但不同接种方案的群体效应尚不清楚。我们的整群随机试验（NCT00534638）评估了仅接种女孩与同时接种女孩和男孩的总体效应和群体效应。在两个学年（2007 - 2008年和2008 - 2009年），我们邀请了80272名1992 - 1995年出生的青少年参加在33个社区进行的整群随机试验，这些社区事先按HPV-16/18血清阳性率低、中、高进行了分层。在11个A组社区，90%参与的女孩和男孩被分配接受HPV-16/18疫苗；在11个B组社区，90%的女孩被分配接受HPV-16/18疫苗，男孩被分配接受乙肝病毒（HBV）疫苗；在11个C组社区，所有人都被分配接受HBV疫苗。在18.5岁时研究接种和未接种疫苗女孩中的HPV流行情况。招募工作使得四个出生队列（1992 - 1995年出生）的入组人数相等，共32175名（40%的应答率）青少年：20514名女孩（各接种组应答率为50.5 - 53.0%）和11661名男孩（各接种组应答率为21.9 - 31.6%）。在15岁时，79.3%的接种者完成了一份问卷。其中>98%居住在研究现场社区，周末有1.3 - 1.6%的人不在社区。不同试验组的吸烟习惯和饮酒情况相似，初潮平均年龄（12.4岁）和首次射精平均年龄（12.6岁）以及性行为（在首次性行为<25%的人群中）在各接种组之间也无差异：女孩和男孩首次性行为的平均年龄分别为14.3岁和14.4岁，15岁时拥有多个（≥5个）终身性伴侣者的比例为（6.5 - 7.5%）。统一的居住、生活方式和性行为特征表明整群随机试验的随机化/入组工作成功。我们的整群随机试验将验证关于适度疫苗接种覆盖率下同时接种女孩和男孩可产生高达31%群体效应的模型预测——量化不同策略的总体有效性，这将很快指导如何实施HPV疫苗接种。
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