Evidence map›Paper›PMID 24610876›Full record

Trial reportThe Journal of infectious diseases2014

Risk of newly detected infections and cervical abnormalities in women seropositive for naturally acquired human papillomavirus type 16/18 antibodies: analysis of the control arm of PATRICIA.

Xavier Castellsagué, Paulo Naud, Song-Nan Chow, Cosette M Wheeler, Maria Julieta V Germar, Matti Lehtinen, Jorma Paavonen, Unnop Jaisamrarn, Suzanne M Garland, Jorge Salmerón and 21 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00122681 (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.), which is not on this map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% 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
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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  7. Immune Responses to Human Papillomavirus After Infection and Vaccination.Current topics in microbiology and immunology · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 13 countries.

Xavier CastellsaguéUnit of Infections and Cancer, Cancer Epidemiology Research Program, Institut Català d'Oncologia, IDIBELL, CIBER-ESP, L'Hospitalet de Llobregat, Catalonia, Spain.
Paulo NaudDepartment of Gynecology and Obstetrics, Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Brazil.
Song-Nan ChowDepartment of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan.
Cosette M WheelerDepartment of Pathology and Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque.
Maria Julieta V GermarDepartment of Obstetrics and Gynaecology, University of the Philippines College of Medicine, Philippine General Hospital, Manila, The Philippines.
Matti LehtinenUniversity of Tampere, School of Public Health, Tampere.
Jorma PaavonenDepartment of Obstetrics and Gynaecology, University of Helsinki, Finland.
Unnop JaisamrarnDepartment of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Suzanne M GarlandDepartment of Microbiology and Infectious Diseases, The Royal Women's Hospital Department of Microbiology, The Royal Children's Hospital, Parkville/Murdoch Childrens Research Institute Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia.
Jorge SalmerónUnidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico.
Dan ApterFamily Federation of Finland, Sexual Health Clinic, Helsinki, Finland.
Henry KitchenerManchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation Trust, St Mary's Hospital, Manchester, United Kingdom.
Julio C TeixeiraDepartamento de Tocoginecologia da Unicamp, University of Campinas, Sao Paulo, Brazil.
S Rachel SkinnerVaccines Trials Group, Telethon Institute for Child Health Research, Perth, Western Australia Sydney University Discipline of Paediatrics and Child Health, Children's Hospital Westmead, Sydney, New South Wales, Australia.
Genara LimsonCollege of Medicine, University of the Philippines, Philippine General Hospital, Makati Medical Centre, Makati City, The Philippines.
Anne SzarewskiCentre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, United Kingdom.
Barbara RomanowskiDivision of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.
Fred Y AokiDepartment of Medical Microbiology, University of Manitoba, Winnipeg, Canada.
Tino F SchwarzCentral Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Germany.
Willy A J PoppeDepartment of Gynaecology, University Hospital KU Leuven Gasthuisberg, Belgium.
F Xavier BoschUnit of Infections and Cancer, Cancer Epidemiology Research Program, Institut Català d'Oncologia, IDIBELL, CIBER-ESP, L'Hospitalet de Llobregat, Catalonia, Spain Network on Cooperative Cancer Research, RTICC, Catalonia, Spain.
Newton S de CarvalhoDepartment of Gynecology and Obstetrics, Federal University of Paraná, Infectious Diseases in Gynecology and Obstetrics Sector, Curitiba, Brazil.
Klaus PetersFacharzt für Frauenheilkunde und Geburtshilfe, Hamburg, Germany.
Wiebren A A TjalmaMultidisciplinary Breast Clinic-Gynecologic Oncology, Antwerp University Hospital, University of Antwerp, Belgium.
Mahboobeh SafaeianDivision of Cancer Epidemiology and Genetics, Infections and Immunoepidemiology Branch, National Cancer Institute, Rockville, Maryland.
Alice Raillard4Clinics, Paris, France.
Dominique DescampsGlaxoSmithKline Vaccines, Wavre, Belgium.
Frank StruyfGlaxoSmithKline Vaccines, Wavre, Belgium.
Gary DubinGlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Dominique RosillonGlaxoSmithKline Vaccines, Wavre, Belgium.
Laurence BarilGlaxoSmithKline Vaccines, Wavre, Belgium.
GlaxoSmithKline (Belgium) · BEInstitut d'Investigació Biomédica de Bellvitge · ESAntwerp University Hospital · BEChulalongkorn University · THGlaxoSmithKline (United States) · USHospital de Clínicas de Porto Alegre · BRKlinik für Frauenheilkunde · DEKU Leuven · BEMakati Medical Center · PHMexican Social Security Institute · MXNational Cancer Institute · USNational Taiwan University Hospital · TWPhilippine General Hospital · PHQueen Mary University of London · GBRoyal Women's Hospital · AUStiftung Juliusspital · DESt Mary's Hospital · GBTampere University · FIThe Kids Research Institute Australia · AUUniversidade Estadual de Campinas (UNICAMP) · BR

Funding

Immune responses to HPV infection and HPV vaccinationZIACP010216 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI HILDESHEIM, ALLAN · 2010 to 2020
$6.5M
6 · The paper itself

Abstract

backgroundWe examined risk of newly detected human papillomavirus (HPV) infection and cervical abnormalities in relation to HPV type 16/18 antibody levels at enrollment in PATRICIA (Papilloma Trial Against Cancer in Young Adults; NCT00122681).

methodsUsing Poisson regression, we compared risk of newly detected infection and cervical abnormalities associated with HPV-16/18 between seronegative vs seropositive women (15-25 years) in the control arm (DNA negative at baseline for the corresponding HPV type [HPV-16: n = 8193; HPV-18: n = 8463]).

resultsHigh titers of naturally acquired HPV-16 antibodies and/or linear trend for increasing antibody levels were significantly associated with lower risk of incident and persistent infection, atypical squamous cells of undetermined significance or greater (ASCUS+), and cervical intraepithelial neoplasia grades 1/2 or greater (CIN1+, CIN2+). For HPV-18, although seropositivity was associated with lower risk of ASCUS+ and CIN1+, no association between naturally acquired antibodies and infection was demonstrated. Naturally acquired HPV-16 antibody levels of 371 (95% confidence interval [CI], 242-794), 204 (95% CI, 129-480), and 480 (95% CI, 250-5756) EU/mL were associated with 90% reduction of incident infection, 6-month persistent infection, and ASCUS+, respectively.

conclusionsNaturally acquired antibodies to HPV-16, and to a lesser extent HPV-18, are associated with some reduced risk of subsequent infection and cervical abnormalities associated with the same HPV type.

Indexed as

AdolescentAdultAntibodies, ViralDNA, ViralDouble-Blind MethodFemaleHuman papillomavirus 16Human papillomavirus 18HumansPapillomaviridaePapillomavirus InfectionsRisk FactorsUterine Cervical DysplasiaUterine Cervical NeoplasmsYoung AdultAntibodies, ViralDNA, Viralcervical abnormalityHPVinfectionnaturally acquired antibodiesrisk reduction

Identifiers

PMID24610876
PMCPMC4111909
OpenAlexW2109956663

What OpenQuestion holds

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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.