Evidence map›Paper›PMID 26685704›Full record

ArticleInternational journal of cancer2016

Progression of HPV infection to detectable cervical lesions or clearance in adult women: Analysis of the control arm of the VIVIANE study.

S Rachel Skinner, Cosette M Wheeler, Barbara Romanowski, Xavier Castellsagué, Eduardo Lazcano-Ponce, M Rowena Del Rosario-Raymundo, Carlos Vallejos, Galina Minkina, Daniel Pereira Da Silva, Shelly McNeil and 15 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in International journal of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00294047 (A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule), which is not on this map. Cited by 54 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 1 pooled it
5.9field-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.

NCT00294047 phase3completednot on this map

A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above

TypeinterventionalSponsorGlaxoSmithKlineRan2006 to 2014Enrolled5,752ConditionsInfections, Papillomavirus, Papillomavirus VaccinesArmsCervarix, Placebo control
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 1 synthesis or guideline pooled it, 116 citations in OpenAlex.

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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

25 authors at 18 institutions in 9 countries.

S Rachel SkinnerVaccines Trials Group, Telethon Institute for Child Health Research, Perth, WA and Sydney University Discipline of Paediatrics and Child Health, Children's Hospital Westmead, Sydney, NSW, Australia.
Cosette M WheelerDepartments of Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
Barbara RomanowskiDivision of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Xavier CastellsaguéUnit of Infections and Cancer, Cancer Epidemiology Research Program, Institut Català d'Oncologia (ICO), IDIBELL, CIBER-ESP, L'Hospitalet de Llobregat, Catalonia, Spain.
Eduardo Lazcano-PonceNational Institute of Public Health, Cuernavaca, Mexico.
M Rowena Del Rosario-RaymundoDepartment of Obstetrics and Gynecology, San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines.
Carlos VallejosDivision de Investigacion Oncosalud-AUNA, Lima, Peru.
Galina MinkinaCity Clinical Hospital, Moscow, Russian Federation.
Daniel Pereira Da SilvaDepartmento de Ginecologia, Instituto Português de Oncologia de Coimbra, Portugal.
Shelly McNeilCanadian Center for Vaccinology, IWK Health Center and Capital Health, Dalhousie University, Halifax, NS, Canada.
Vera PrilepskayaScientific Center of Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, Moscow, Russian Federation.
Irina GogotadzeCity Medical Center, St Petersburg, Russian Federation.
Deborah MoneyUniversity of British Columbia, The Women's Health Research Institute, Vancouver, British Columbia, Canada.
Suzanne M GarlandDepartment of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville/Department of Microbiology, The Royal Children's Hospital, Parkville/Murdoch Children's Research Institute, Parkville/Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia.
Viktor RomanenkoCity Children's Hospital N40, Ekaterinburg, Russian Federation.
Diane M HarperGeisel School of Medicine at Dartmouth, Hanover, NH, USA and University of Louisville School of Medicine, Louisville, KT, USA.
Myron J LevinSection of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, USA.
Archana ChatterjeeDepartment of Pediatrics, University of South Dakota Sanford School of Medicine/Sanford Children's Specialty Clinic, Sioux Falls, SD, USA.
Brecht GeeraertsGSK Vaccines, Wavre, Belgium.
Frank StruyfGSK Vaccines, Wavre, Belgium.
Gary DubinGSK Vaccines, King of Prussia, PA, USA.
Marie-Cécile Bozonnat4Clinics, Paris, France.
Dominique RosillonGSK Vaccines, Wavre, Belgium.
Laurence BarilGSK Vaccines, Wavre, Belgium.
VIVIANE Study Group
GlaxoSmithKline (Belgium) · BECapital District Health Authority · CAChildren's City Clinical Hospital №11 · RUCity Clinical Hospital · RUCity Clinical Oncology Center · RUEsSALUD · PEInstitut Català d'Oncologia · ESInstituto Nacional de Salud Pública · MXInstituto Português de Oncologia de Coimbra Francisco Gentil · PTNational Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Healthcare of the Russian Federation · RUThe University of Melbourne · AUThe University of Sydney · AUUniversity of Alberta · CAUniversity of British Columbia · CAUniversity of Colorado Denver · USUniversity of Louisville · USUniversity of New Mexico · USUniversity of South Dakota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The control arm of the phase III VIVIANE (Human PapillomaVIrus: Vaccine Immunogenicity ANd Efficacy; NCT00294047) study in women >25 years was studied to assess risk of progression from cervical HPV infection to detectable cervical intraepithelial neoplasia (CIN). The risk of detecting CIN associated with the same HPV type as the reference infection was analysed using Kaplan-Meier and multivariable Cox models. Infections were categorised depending upon persistence as 6-month persistent infection (6MPI) or infection of any duration. The 4-year interim analysis included 2,838 women, of whom 1,073 (37.8%) experienced 2,615 infections of any duration and 708 (24.9%) experienced 1,130 6MPIs. Infection with oncogenic HPV types significantly increased the risk of detecting CIN grade 2 or greater (CIN2+) versus non-oncogenic types. For 6MPI, the highest risk was associated with HPV-33 (hazard ratio [HR]: 31.9 [8.3-122.2, p < 0.0001]). The next highest risk was with HPV-16 (21.1 [6.3-70.0], p < 0.0001). Similar findings were seen for infections of any duration. Significant risk was also observed for HPV-18, HPV-31, and HPV-45. Concomitant HPV infection or CIN grade 1 or greater associated with a different oncogenic HPV type increased risk. Most women (79.3%) with an HPV infection at baseline cleared detectable infections of any duration, and 69.9% cleared a 6MPI. The risk of progression of HPV infection to CIN2+ in women >25 years in this study was similar to that in women 15-25 years in PATRICIA.

Indexed as

AdultAlphapapillomavirusClinical Trials, Phase III as TopicDisease ProgressionEarly Detection of CancerFemaleFollow-Up StudiesHumansMiddle AgedPapillomavirus InfectionsPapillomavirus VaccinesPublic Health SurveillanceRiskUterine Cervical DysplasiaUterine Cervical NeoplasmsPapillomavirus Vaccinesadult womenCINHPVnatural historyVIVIANE

Identifiers

PMID26685704
PMCPMC4787275
OpenAlexW2207792382

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.