Evidence map›Paper›PMID 41162330›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

Anal Human Papillomavirus Infection Progression to Disease Among Men Who Have Sex With Men.

Joel M Palefsky, Anna R Giuliano, Stephen E Goldstone, Brady Dubin, Alfred Saah, Alain Luxembourg, Christine Velicer, Joseph E Tota

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00090285 (An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT00090285 phase3completednot on this map

An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2004 to 2017Enrolled4,065ConditionsCondylomata AcuminataArms(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, Comparator: placebo (unspecified)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Joel M PalefskyDepartment of Medicine, University of California San Francisco, San Francisco, California, USA.ORCID 0000-0002-5097-3818
Anna R GiulianoCenter for Immunization and Infection Research in Cancer (CIIRC), Moffitt Cancer Center, Tampa, Florida, USA.
Stephen E GoldstoneDepartment of Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Brady DubinMerck Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.
Alfred SaahGlobal Medical and Scientific Affairs, Merck Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.
Alain LuxembourgVaccine Clinical Development, Merck Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.
Christine VelicerDepartment of Epidemiology, Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.
Joseph E TotaDepartment of Epidemiology, Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.

Funding

Merck & Co., Inc.Merck Sharp & Dohme LLC
6 · The paper itself

Abstract

backgroundCritical gaps exist in our understanding of the progression from anal human papillomavirus (HPV) infection to same-type HPV-associated anal disease in human immunodeficiency virus (HIV)-negative men who have sex with men (MSM). We conducted a post hoc analysis of a phase 3 randomized 4-valent HPV vaccine trial (NCT00090285) to assess the natural progression of anal HPV infections to associated anal lesions among MSM.

participantsA total of 602 HIV-negative MSM aged 16-27 years.

methodsHIV-negative MSM aged 16-27 years enrolled in the placebo arm from 18 countries were included. We estimated the distribution of 9-valent HPV (9vHPV) vaccine types in intra-anal lesions (anal condyloma and anal intraepithelial neoplasia [AIN] 1-3), proportions and rates of progression from incident-persistent (no associated anal disease at baseline) intra-anal HPV infections to the same-type HPV-associated anal lesion, and cumulative incidence over 30 months.

resultsPredominant 9vHPV types detected were HPV6 (55.7%) and HPV11 (25.3%) in MSM with anal condyloma/AIN1, and HPV6 (30.5%), HPV16 (22.0%), and HPV11 (15.3%) in those with pooled AIN2/3. Progression from incident-persistent intra-anal 9vHPV infection to anal disease was driven primarily by HPV6, HPV11, and HPV16/18 infections for MSM with anal condyloma/AIN1 (63.0%, 85.7%, and 16.3%, respectively) and AIN2/3 (25.9%, 14.3%, and 32.4%, respectively). Cumulative incidence of anal condyloma/AIN1 and AIN2/3 in MSM with incident-persistent infection was 43.1% and 34.4%, respectively.

conclusionsA high proportion of unvaccinated HIV-negative MSM with a new intra-anal 9vHPV infection developed same-type HPV-associated anal disease. These findings support HPV vaccination of young HIV-negative MSM to prevent anal HPV infection and associated anal disease. REGISTRATION: ClinicalTrials.gov, NCT00090285.

Indexed as

Anus DiseasesHomosexuality, MalePapillomavirus InfectionsAdolescentAdultAnal CanalAnus NeoplasmsDisease ProgressionHumansIncidenceMalePapillomaviridaePapillomavirus VaccinesSexual and Gender MinoritiesYoung AdultPapillomavirus Vaccinesanal condylomaanal intraepithelial neoplasiaHPV infectionHPV vaccineshuman papillomavirus

Identifiers

PMID41162330
PMCPMC13016981

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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.