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

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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

Title: Effectiveness of various human papillomavirus vaccination strategies : A community randomized trial in Finland
Author: Lehtinen, Matti; Apter, Dan; Eriksson, Tiina; Harjula, Katja; Hokkanen, Mari; Natunen, Kari; Nieminen, Pekka; Paavonen, Jorma; Palmroth, Johanna; Petaja, Tiina; Pukkala, Eero; Vänskä, Simopekka; Cheuvart, Brigitte; Soila, Maaria; Bi, Dan; Struyf, Frank
Contributor: University of Helsinki, HUS Gynecology and Obstetrics
University of Helsinki, HUS Gynecology and Obstetrics
Date: 2021-11
Language: eng
Number of pages: 13
Belongs to series: Cancer medicine
ISSN: 2045-7634
URI: http://hdl.handle.net/10138/336609
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.
Subject: community
gender-neutral
human papillomavirus
vaccination strategy
HPV-16/18 AS04-ADJUVANTED VACCINE
OF-STUDY ANALYSIS
DOUBLE-BLIND
HPV VACCINE
INTRAEPITHELIAL NEOPLASIA
PARTICLE VACCINE
SEXUAL-BEHAVIOR
YOUNG-WOMEN
INFECTION
EFFICACY
3122 Cancers
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