ArticleVaccine2025
Design of a multicenter, randomized, double-blinded, placebo-controlled phase III trial evaluating the 9-valent human papillomavirus (HPV) vaccine to prevent persistent oral HPV infection in men living with human immunodeficiency virus: ULACNet trial 201.
Article in Vaccine, 2025. 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 3 papers.
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.
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.
A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age
Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV
Who cites it
3 citing papers in PubMed.
- Genotype distribution of human papillomavirus (HPV) types in oral gargle specimens among men living with HIV in Mexico, Brazil, and Puerto Rico: A cross-sectional study.The Journal of infection · 2026Trial
- Alcohol consumption and oral human papillomavirus infection among men living with HIV: a cross-sectional study from the ULACNet 201 trial.Scientific reports · 2026Trial
- Clinical research progress and challenges of vaccine for human papillomavirus-associated cancers.Human vaccines & immunotherapeutics · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
HPV-related oropharyngeal squamous cell carcinoma (OPSCC) has increased significantly among men, especially among men living with HIV. HPV vaccines have proven efficacy in preventing persistent anogenital HPV infections. However, less is known regarding vaccine efficacy against persistent oral HPV infection, the obligate precursor of OPSCC. In 2020, the 9-valent HPV (9vHPV) vaccine received accelerated approval from the FDA for the indication of prevention of HPV-related OPSCC and other head and neck cancers, pending confirmation of clinical benefit in further trials. Currently a Phase III trial is ongoing to evaluate efficacy of the 9vHPV vaccine in preventing persistent oral HPV infection in immunocompetent men (NCT04199689); however, no trials have been conducted in people living with HIV. Here we describe the rationale, design, and study population characteristics of the first randomized (1:1), double-blind, placebo-controlled trial evaluating the efficacy and immunogenicity of the 9vHPV vaccine in preventing persistent oral HPV infection in men aged 20-50 living with HIV. The primary objective is to demonstrate that the 9vHPV vaccine when given in a 3-dose regimen (Day 1, Months 2 and 6) reduces the incidence of persistent (≥6 months) oral HPV infection with 9vHPV vaccine types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in men living with HIV who are oral HPV negative to the relevant HPV type at enrollment, compared with placebo. The trial began in February 2021 and completed enrollment of 700 men at clinical sites in Brazil, Mexico, and Puerto Rico in February 2024. The secondary objectives are to evaluate the vaccine-induced serum anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 responses, and the safety and tolerability of the 9vHPV vaccine in men living with HIV. Results from this study may inform policy regarding vaccination strategies for people living with HIV. ClinicalTrials.gov Identifier: NCT04255849.
Indexed as
Identifiers
What OpenQuestion holds
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.