Ten-year follow-up of human papillomavirus vaccine efficacy against the most stringent cervical neoplasia end-point-registry-based follow-up of three cohorts from randomized trials

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Lehtinen , M , Lagheden , C , Luostarinen , T , Eriksson , T , Apter , D , Harjula , K , Kuortti , M , Natunen , K , Palmroth , J , Petaja , T , Pukkala , E , Siitari-Mattila , M , Struyf , F , Nieminen , P , Paavonen , J , Dubin , G & Dillner , J 2017 , ' Ten-year follow-up of human papillomavirus vaccine efficacy against the most stringent cervical neoplasia end-point-registry-based follow-up of three cohorts from randomized trials ' , BMJ Open , vol. 7 , no. 8 , 015867 . https://doi.org/10.1136/bmjopen-2017-015867

Title: Ten-year follow-up of human papillomavirus vaccine efficacy against the most stringent cervical neoplasia end-point-registry-based follow-up of three cohorts from randomized trials
Author: Lehtinen, Matti; Lagheden, Camilla; Luostarinen, Tapio; Eriksson, Tiina; Apter, Dan; Harjula, Katja; Kuortti, Marjo; Natunen, Kari; Palmroth, Johanna; Petaja, Tiina; Pukkala, Eero; Siitari-Mattila, Mari; Struyf, Frank; Nieminen, Pekka; Paavonen, Jorma; Dubin, Gary; Dillner, Joakim
Contributor: University of Helsinki, Clinicum
University of Helsinki, Clinicum
Date: 2017-08
Language: eng
Number of pages: 8
Belongs to series: BMJ Open
ISSN: 2044-6055
URI: http://hdl.handle.net/10138/228361
Abstract: Objective Due to long lag time between infection/ cancer diagnoses human papillomavirus (HPV) vaccination programs will deliver vaccine efficacy (VE) estimates against cancer end-points late. Cancer registry follow-up of population-based, randomised trial cohorts of vaccinated and unvaccinated women was undertaken for the estimation of VE against cervical intraepithelial neoplasia grade three and invasive cancer (CIN3+). Methods We report interim results with 98 561 person years of Finnish Cancer Registry -based follow-up of individually and/or cluster randomised cohorts of HPV-16/ 18 vaccinated and unvaccinated adolescent women enrolled in June 2003/2005, and between May 2004 and April 2005, respectively. The cohorts comprised 15 627 18-to 19-year-old unvaccinated women (NCT01393470), and 2 401 and 64 16-to 17-year-old HPV-16/18 vaccinated women participating the PATRICIA (NCT00122681) and HPV-012 (NCT00169494) trials, respectively. The age-aligned passive follow-up started 6 months after the clinical trials' end. Results During the follow-up of 4.5 to 10 years post enrolment we identified 75 cases of cervical intraepithelial neoplasia grade 3 (CIN3) and 4 cases of invasive cervical cancer (ICC) in the unvaccinated cohort, and 4 CIN3 cases in the HPV-16/18 vaccinated women. Diagnostic blocks were available for HPV typing from 87% of the cases. CIN3+ lesions were detectable in 54 cases. HPV16 was found in 26 of 50 unvaccinated CIN3+ cases, and in 3 CIN3+ cases in the HPV-16/18 vaccinated women. The latter were all baseline positive for cervical HPV16 DNA. Baseline data was not available for the unvaccinated women. Intention-to-treat VE against any CIN3+ was 66% (95% CI 8, 88). Conclusions Ten years post vaccination the AS04-adjuvanted HPV-16/18 vaccine shows continued efficacy against CIN3+ irrespectively of HPV type. Vaccine efficacy was not observed in baseline HPV16 DNA positive subjects.
Subject: HPV-16/18 AS04-ADJUVANTED VACCINE
BLIND PATRICIA TRIAL
YOUNG-WOMEN
INTRAEPITHELIAL NEOPLASIA
HEPATOCELLULAR-CARCINOMA
HEPATITIS-B
INFECTION
ENROLLMENT
CHILDREN
IMPACT
3121 Internal medicine
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