Effectiveness of various human papillomavirus vaccination strategies : A community randomized trial in Finland

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dc.contributor.author Lehtinen, Matti
dc.contributor.author Apter, Dan
dc.contributor.author Eriksson, Tiina
dc.contributor.author Harjula, Katja
dc.contributor.author Hokkanen, Mari
dc.contributor.author Natunen, Kari
dc.contributor.author Nieminen, Pekka
dc.contributor.author Paavonen, Jorma
dc.contributor.author Palmroth, Johanna
dc.contributor.author Petaja, Tiina
dc.contributor.author Pukkala, Eero
dc.contributor.author Vänskä, Simopekka
dc.contributor.author Cheuvart, Brigitte
dc.contributor.author Soila, Maaria
dc.contributor.author Bi, Dan
dc.contributor.author Struyf, Frank
dc.date.accessioned 2021-11-23T07:19:01Z
dc.date.available 2021-11-23T07:19:01Z
dc.date.issued 2021-11
dc.identifier.citation Lehtinen , M , Apter , D , Eriksson , T , Harjula , K , Hokkanen , M , Natunen , K , Nieminen , P , Paavonen , J , Palmroth , J , Petaja , T , Pukkala , E , Vänskä , S , Cheuvart , B , Soila , M , Bi , D & Struyf , F 2021 , ' Effectiveness of various human papillomavirus vaccination strategies : A community randomized trial in Finland ' , Cancer medicine , vol. 10 , no. 21 , pp. 7759-7771 . https://doi.org/10.1002/cam4.4299
dc.identifier.other PURE: 170549581
dc.identifier.other PURE UUID: 9451ec54-4263-41ec-a4bb-ea18c96146e2
dc.identifier.other WOS: 000700349100001
dc.identifier.other ORCID: /0000-0003-4775-606X/work/103659851
dc.identifier.uri http://hdl.handle.net/10138/336609
dc.description.abstract Introduction We conducted a community-randomized trial (NCTBLINDED) in Finland to assess gender-neutral and girls-only vaccination strategies with the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18)vaccine. Methods Girls and boys (12-15 years) were invited. We randomized 33 communities (1:1:1 ratio): Arm A: 90% of randomly selected girls and boys received AS04-HPV-16/18 vaccine and 10% received hepatitis B vaccine (HBV); Arm B: 90% of randomly selected girls received AS04-HPV-16/18 vaccine, 10% of girls received HBV, and all boys received HBV; Arm C: all participants received HBV. Effectiveness measurements against prevalence of HPV-16/18 cervical infection were estimated in girls at 18.5 years. The main measures were: (1) overall effectiveness comparing Arms A or B, regardless of vaccination status, vs Arm C; (2) total effectiveness comparing AS04-HPV-16/18 vaccinated girls in pooled Arms A/B vs Arm C; (3) indirect effectiveness (herd effect) comparing girls receiving HBV or unvaccinated in Arm A vs Arm C. Co-primary objectives were overall effectiveness following gender-neutral or girls-only vaccination. Results Of 80,272 adolescents invited, 34,412 were enrolled. Overall effectiveness was 23.8% (95% confidence interval: -19.0, 51.1; P = 0.232) with gender-neutral vaccination. Following girls-only vaccination, overall effectiveness was 49.6% (20.1, 68.2; P = 0.004). Total effectiveness was over 90% regardless of vaccination strategy. No herd effect was found. Immunogenicity of the AS04-HPV-16/18 vaccine was high in both sexes. Conclusions This study illustrates the difficulty in conducting community randomized trials. It is not plausible that vaccinating boys would reduce overall effectiveness, and the apparent lack of herd effect was unexpected given findings from other studies. This analysis was likely confounded by several factors but confirms the vaccine's high total effectiveness as in clinical trials. en
dc.format.extent 13
dc.language.iso eng
dc.relation.ispartof Cancer medicine
dc.rights cc_by
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject community
dc.subject gender-neutral
dc.subject human papillomavirus
dc.subject vaccination strategy
dc.subject HPV-16/18 AS04-ADJUVANTED VACCINE
dc.subject DOUBLE-BLIND
dc.subject HPV VACCINE
dc.subject YOUNG-WOMEN
dc.subject INFECTION
dc.subject EFFICACY
dc.subject 3122 Cancers
dc.title Effectiveness of various human papillomavirus vaccination strategies : A community randomized trial in Finland en
dc.type Article
dc.contributor.organization HUS Gynecology and Obstetrics
dc.contributor.organization Clinicum
dc.contributor.organization Department of Obstetrics and Gynecology
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1002/cam4.4299
dc.relation.issn 2045-7634
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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