Evidence map›Paper›PMID 27541373›Full record

ArticleInternational journal of cancer2016

Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial.

Suzanne M Garland, Jorma Paavonen, Unnop Jaisamrarn, Paulo Naud, Jorge Salmerón, Song-Nan Chow, Dan Apter, Xavier Castellsagué, Júlio C Teixeira, S Rachel Skinner and 15 more

2 registry-linked trialsOpen access · bronzeAbstract 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 2 registered trials, which are not on this map. Cited by 51 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 10 pooled it
6.2field-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
NCT06686043 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 2 Study of HPV L1 Vaccine in Combination With Imiquimod and Metformin in Cervical, Vaginal, and Vulvar Cancers

TypeinterventionalSponsorBaylor College of MedicineRan2024 to 2028Enrolled85ConditionsCervical Carcinoma, Vaginal Carcinoma, Vulvar Carcinoma, HPV (Human Papillomavirus)-Associated CarcinomaArmsHPV vaccine, Imiquimod, and metformin combination therapy
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 10 syntheses or guidelines pooled it, 101 citations in OpenAlex.

  1. Guideline
  2. Prophylactic HPV vaccination in HPV-related gynecologic cancers: European Society of Gynecological Oncology (ESGO) prevention committee opinion.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Guideline
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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 20 institutions in 11 countries.

Suzanne M GarlandMicrobiology and Infectious Diseases Department, Royal Women's Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia. suzanne.garland@thewomens.org.au.
Jorma PaavonenDepartment of Obstetrics and Gynaecology, University of Helsinki, Finland.
Unnop JaisamrarnDepartment of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Paulo NaudUniversity Federal of Rio Grande do Sul, Hospital de Clínica de Porto Alegre, Brazil.
Jorge SalmerónUnidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico.
Song-Nan ChowDepartment of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan.
Dan ApterFamily Federation of Finland, Sexual Health Clinic, Helsinki, Finland to VL-Medi Research Center, Helsinki, Finland.
Xavier CastellsaguéInstitut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain.
Júlio C TeixeiraDepartment of Gynecology, Oncology Division-CAISM, State University of Campinas, Campinas, Brazil.
S Rachel SkinnerVaccine Trials Group, Telethon Institute for Child Health Research, Sydney, NSW, Australia.
James HedrickKentucky Pediatric and Adult Research, Bardstown, KY, USA.
Genara LimsonMakati Medical Centre, University of the Philippines, College of Medicine, Philippine General Hospital, Makati City, Philippines.
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, Leuven, Belgium.
F Xavier BoschInstitut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain.
Newton S de CarvalhoDepartment of Gynecology and Obstetrics, Federal University of Paraná, Infectious Diseases in Gynecology and Obstetrics Sector, Curitiba, Paraná, Brazil.
Maria Julieta V GermarUniversity of the Philippines College of Medicine, Philippine General Hospital, Manila, Philippines.
Klaus PetersFacharzt für Frauenheilkunde und Geburtshilfe, Hamburg, Germany.
M Rowena Del Rosario-RaymundoSan Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines.
Grégory CatteauGSK Vaccines, Belgium.
Dominique DescampsGSK Vaccines, Belgium.
Frank StruyfGSK Vaccines, Belgium.
Matti LehtinenSchool of Public Health, University of Tampere, Finland.
Gary DubinGlaxoSmithKline, King of Prussia, PA, USA.
HPV PATRICIA Study Group
GlaxoSmithKline (Belgium) · BEChildren's Hospital at Westmead · AUChulalongkorn University · THGlaxoSmithKline (United States) · USGlobal Vaccines (United States) · USHospital de Clínicas de Porto Alegre · BRInstitut Català d'Oncologia · ESInstitut d'Investigació Biomédica de Bellvitge · ESKlinik für Frauenheilkunde · DEMakati Medical Center · PHMexican Social Security Institute · MXNational Taiwan University Hospital · TWOhio Pediatric Research Association · USPhilippine General Hospital · PHRoyal Women's Hospital · AUSexual Health Clinic · FIStiftung Juliusspital · DETampere University · FIUniversidade Estadual de Campinas (UNICAMP) · BRUniversidade Federal do Paraná · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+.

Indexed as

Adjuvants, ImmunologicAdolescentAdultFemaleHuman papillomavirus 16Human papillomavirus 18HumansNeoplasm GradingNeoplasm Recurrence, LocalOutcome Assessment, Health CarePapillomavirus InfectionsPapillomavirus VaccinesRandomized Controlled Trials as TopicRisk FactorsUterine Cervical DysplasiaVaccinationAdjuvants, ImmunologicPapillomavirus Vaccinescervical intraepithelial neoplasiaclinical trialhuman papillomavirus vaccinetreatment

Identifiers

PMID27541373
PMCPMC5412942
OpenAlexW2507903272

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.