Evidence map›Paper›PMID 19116707›Full record

Trial reportWiener klinische Wochenschrift2008

Prevalence of human papillomavirus types 6, 11, 16 and 18 in young Austrian women - baseline data of a phase III vaccine trial.

Lucia Six, Sepp Leodolter, Heather L Sings, Eliav Barr, Richard Haupt, Elmar A Joura

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Wiener klinische Wochenschrift, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00092521 (A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 41% 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.

NCT00092521 phase3completednot on this map

A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2001 to 2009Enrolled5,759ConditionsCervical Cancer, Genital WartsArmsV501, Comparator: Placebo, Human Papillomavirus (HPV) 16 Monovalent
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
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

6 authors at 2 institutions in 2 countries.

Lucia SixDepartment of Gynecology and Obstetrics, Women's Health Clinic, Medical University of Vienna, Vienna, Austria. lucia.six@meduniwien.ac.at
Sepp Leodolter
Heather L Sings
Eliav Barr
Richard Haupt
Elmar A Joura
Medical University of Vienna · ATUnited States Military Academy · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCervical cancer is the second most common cancer among women worldwide. In the absence of changing risk or intervention, it is projected that in comparison with 2002 there will be a 40% increase in the number of new cases of cervical cancer by 2020. HPV types 16 and 18 cause 70% of cervical cancers worldwide, 50% of high-grade cervical intraepithelial neoplasias and 25% of low-grade neoplasias. HPV types 6 and 11 are the causative agent of > 90% of genital warts. The aim of this study was to assess the baseline prevalence of infection with HPV 6, 11, 16 and 18 in young Austrian women.

methodsAustrian females aged 16-24 (n = 123) were enrolled in a double-blind, placebo-controlled, randomized phase III trial of a quadrivalent HPV (types 6, 11, 16, 18) vaccine (FUTURE I, ClinicalTrials.gov number NCT00092521). Healthy women who were not pregnant and had no prior history of genital warts or abnormal results on cervical cytologic testing and had fewer than five lifetime sex partners were eligible for enrollment. The study sub-population was recruited primarily from university settings.

resultsAnalysis of the sexual history of the Austrian subjects showed that 92.7% (114/123) were non-virgins and 46.3% were current smokers. At enrollment, 15 (13.5%) had positive serological or PCR tests for HPV 6, 11, 16 or 18. Serologically, 14 (12.3%) of women were positive to HPV 6, 11, 16 or 18: of these, 13 (11.4%) were positive for HPV 16, four (3.5%) were positive for HPV 18, and one (0.9%) for HPV 6. By PCR all were negative for HPV 6 and 11, whereas seven (6.1%) were positive for HPV 16 and one (0.9%) for HPV 18. Abnormal cytology was observed in 12 (10.3%) women. DISCUSSION: Although the prevalence of vaccine HPV types among young Austrian women with fewer than five lifetime sexual partners was lower than in international data, we observed a high prevalence of abnormal cytology and smoking. These data suggest that a substantial number of Austrian women are at risk for HPV-related disease.

Indexed as

AdolescentAdultAlphapapillomavirusAustriaComorbidityDouble-Blind MethodFemaleHuman papillomavirus 11Human papillomavirus 16Human papillomavirus 18Human papillomavirus 6HumansPapillomavirus InfectionsPapillomavirus VaccinesPrevalenceRisk AssessmentPapillomavirus Vaccines

Identifiers

PMID19116707
OpenAlexW254693018

What OpenQuestion holds

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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.