Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial. Issue 10 (3rd March 2015)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Vaccine. Volume 33:Issue 10(2015)
• Page Start: 1284
• Page End: 1290
• Publication Date: 2015-03-03
• Subjects: Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2014.12.019
• Languages: English
• ISSNs: 0264-410X

Abstract

<abstract abstract-type="author" id="abs0005"> <title id="sect0005">Abstract</title> <sec> <p id="spar0005">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 (<ext-link ext-link-type="unknown" id="intr1005" xlink:type="simple" xlink:href="ctgov:NCT00534638" xmlns:xlink="http://www.w3.org/1999/xlink">NCT00534638</ext-link>) 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.</p> </sec> </abstract>