Evidence map›Paper›PMID 40394508›Full record

ArticleBMC cancer2025

Adjuvant nonavalent HPV vaccination in women treated for vulvar HSIL, a randomized placebo-controlled trial; VulVaccin study protocol.

Vera J G M Vaessen, Ralf L O van de Laar, Marta Piso-Jozwiak, Virgil A S H Dalm, Elmar A Joura, Matthias Jentschke, Heleen J van Beekhuizen

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06052696 (Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL, a Randomised Placebo Controlled Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT06052696 phase4not yet recruitingnot on this map

Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL, a Randomised Placebo Controlled Trial

TypeinterventionalSponsorErasmus Medical CenterRan2023 to 2030Enrolled500ConditionsVulvar HSIL, HPVArmsGardasil 9 Suspension for Injection, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Spatio-temporal inequalities in vulvar cancer mortality in Spain, 1999-2023: a nationwide Bayesian analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    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

7 authors.

Vera J G M Vaessen *Department of Gynaecological Oncology, ErasmusMC Cancer Institute, University Medical Center Rotterdam, Rotterdam, 3015 GD, The Netherlands. v.vaessen@erasmusmc.nl.
Ralf L O van de Laar *Department of Gynaecological Oncology, ErasmusMC Cancer Institute, University Medical Center Rotterdam, Rotterdam, 3015 GD, The Netherlands.
Marta Piso-JozwiakDepartment of Gynaecological Oncology, ErasmusMC Cancer Institute, University Medical Center Rotterdam, Rotterdam, 3015 GD, The Netherlands.
Virgil A S H DalmDepartment of Internal Medicine, Division of Allergy & Clinical Immunology, Department of Immunology, Erasmus University Medical Center Rotterdam, Rotterdam, 3015 GD, The Netherlands.
Elmar A JouraDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center, the Medical University of Vienna, BT86/E 01, Spitalgasse 23, Vienna, 1090, Austria.
Matthias JentschkeDepartment of Gynecology and Obstetrics, Klinikum Würzburg Mitte, Würzburg, 97074, Germany.
Heleen J van BeekhuizenDepartment of Gynaecological Oncology, ErasmusMC Cancer Institute, University Medical Center Rotterdam, Rotterdam, 3015 GD, The Netherlands.

Funding

KWF Kankerbestrijding 2023-1 DEV/14995
6 · The paper itself

Abstract

backgroundEach year, 45,000 women worldwide develop vulvar cancer, often occurred from vulvar high-grade squamous intraepithelial lesions (vHSIL), a precancerous stage associated with high- risk human papillomavirus (HPV). Recurrent vHSIL, experienced by over 30% of patients despite treatment, conducting in significant physical and psychosocial challenges. With no established method to reduce recurrence, our study investigates the potential of adjuvant HPV vaccination during treatment. We aim to determine whether nonavalent HPV vaccination can effectively prevent vHSIL recurrence in women treated for vulvar HSIL.

methodsThis is a randomized, double-blind, placebo-controlled study protocol involving 498 women diagnosed with vHSIL. Participants will be randomized to receive either the nonavalent HPV vaccine or a placebo in addition to standard treatment. The primary outcome is the recurrence of vHSIL within 24 months following treatment. Secondary endpoints are treatment effectiveness, immune response, cost-effectiveness, and quality of life. Long-term follow-up examines vaccine effect after 5 and 10 years, along with the occurrence of vulvar malignancies. Relative risk between vaccinated and placebo groups will be evaluated, employing intention-to-treat principles. DISCUSSION: This study is designed to investigate the potential benefits of HPV vaccination in managing vHSIL. Results from the trial will provide evidence on the vaccine's impact on recurrence rates, treatment outcomes, and long-term prevention of vulvar malignancies.

trial registrationClinicalTrials.gov. Identifier: NCT06052696. Registered 12 January 2023, https://clinicaltrials.gov/study/NCT06052696 .

Indexed as

Neoplasm Recurrence, LocalPapillomavirus InfectionsPapillomavirus VaccinesSquamous Intraepithelial LesionsVulvar NeoplasmsAdultCost-Benefit AnalysisDouble-Blind MethodFemaleHumansMiddle AgedQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeVaccinationYoung AdultPapillomavirus VaccinesAdjuvant HPV vaccinationPapillomavirus vaccinesVulvar cancerVulvar high-grade squamous intraepithelial lesionVulvar HSIL treatmentVulvar neoplasms

Identifiers

PMID40394508
PMCPMC12093810

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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.