Evidence map›Paper›PMID 28821519›Full record

Trial reportBMJ open2017

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

Matti Lehtinen, Camilla Lagheden, Tapio Luostarinen, Tiina Eriksson, Dan Apter, Katja Harjula, Marjo Kuortti, Kari Natunen, Johanna Palmroth, Tiina Petäjä and 7 more

5 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 56 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 8 pooled it
6.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00122681 phase3completednot on this map

A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2009Enrolled18,729ConditionsInfections, PapillomavirusArmsCervarix™, Havrix™-based investigational formulation
NCT00169494 phase3completednot on this map

Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2005Enrolled770ConditionsInfections, PapillomavirusArmsHPV-16/18 L1/AS04
NCT01393470 unknown statusnot on this map

A Long-term Follow-up Registry-based Cohort Study of HPV Vaccine Efficacy Against Cervical Pre-cancerous Lesions and Cervical Cancers in a Cohort of Females Previously Enrolled From Finland in Study HPV-008, as Compared to a Non-intervention Population -Based Reference Cohort of Females From Finland

TypeobservationalSponsorTampere UniversityRan2011 to 2024Enrolled10,000ConditionsUterine Cervical CancerArmsScreening for cervical cancer
NCT04920526 unknown statusnot on this mapstarted 2021, after this paper: background citation

Effectiveness of the QHPV Among Kenyan HIV Infected Girls and Boys 9 Years Post Vaccination

TypeobservationalSponsorKenya Medical Research InstituteRan2021 to 2022Enrolled135ConditionsHPV-Related CarcinomaArmsQuadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine
NCT06700941 completednot on this map

Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment

TypeobservationalSponsorUniversidad Nacional de ColombiaRan2012 to 2020Enrolled8,000,000ConditionsCervical Intraepithelial Neoplasia (CIN), Genital Warts, Papillomavirus Infections, Cervical CancersArmsHPV vaccine
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 8 syntheses or guidelines pooled it, 88 citations in OpenAlex.

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  17. HPV vaccination associates withFrontiers in microbiology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 4 countries.

Matti LehtinenUniversity of Tampere, Tampere, Finland.
Camilla LaghedenDepartment of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.
Tapio LuostarinenDepartment of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.
Tiina ErikssonUniversity of Tampere, Tampere, Finland.
Dan ApterVL-Medi, Helsinki, Finland.
Katja HarjulaUniversity of Tampere, Tampere, Finland.
Marjo KuorttiUniversity of Tampere, Tampere, Finland.
Kari NatunenUniversity of Tampere, Tampere, Finland.
Johanna PalmrothUniversity of Tampere, Tampere, Finland.
Tiina PetäjäUniversity of Tampere, Tampere, Finland.
Eero PukkalaFinnish Cancer Registry, Helsinki, Finland.
Mari Siitari-MattilaUniversity of Tampere, Tampere, Finland.
Frank StruyfGSK Biologicals, Wavre, Belgium.
Pekka NieminenUniversity of Helsinki, Helsinki, Finland.
Jorma PaavonenUniversity of Helsinki, Helsinki, Finland.
Gary DubinTakeda Pharmaceuticals International, Zurich, Switzerland.
Joakim DillnerDepartment of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.
Karolinska Institutet · SETampere University · FITampere University · FIUniversity of Helsinki · FIFinnish Cancer Registry · FIQ-Biologicals (Belgium) · BETakeda (Switzerland) · CHVL-Medi Oy (Finland) · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDue 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+).

methodsWe 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.

resultsDuring 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).

conclusionsTen 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. TRIAL REGISTRATION NUMBER: NCT01393470.

Indexed as

Papillomavirus VaccinesVaccinationAdjuvants, ImmunologicAdolescentAdultDNA, ViralDouble-Blind MethodFemaleFinlandFollow-Up StudiesHuman papillomavirus 16Human papillomavirus 18HumansIncidenceIntention to Treat AnalysisNeoplasm GradingAdjuvants, ImmunologicDNA, ViralPapillomavirus Vaccinescervical cancercin3+HPV vaccineslong-term follow-uprandomized controlled trialvaccine efficacy

Identifiers

PMID28821519
PMCPMC5629648
OpenAlexW2747684038

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.