Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
A Randomized, Placebo-Controlled Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Adults Aged 27 Years or Older: AIDS Clinical Trials Group Protocol A5298.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. 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 81 papers, 7 of them syntheses that pooled 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.
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 Randomized, Double-Blinded, Placebo-Controlled, Phase III Trial of the Quadrivalent HPV Vaccine to Prevent Anal Human Papillomavirus Infection in HIV-Infected Men and Women
Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.
Who cites it
81 citing papers in PubMed, 7 syntheses or guidelines pooled it, 137 citations in OpenAlex.
- Immunogenicity and safety of prophylactic HPV vaccines in people living with HIV: A systematic review and meta-analysis.Human vaccines & immunotherapeutics · 2026Pooled it
- Comparing and contrasting clinical consensus and guidelines for anal intraepithelial neoplasia in different geographical regions.Updates in surgery · 2021Pooled it
- Updated clinical guideline for human papillomavirus vaccine: the Korean Society of Gynecologic Oncology guidelines.Journal of gynecologic oncology · 2021Guideline
- Efficacy and safety of human papillomavirus vaccination in HIV-infected patients: a systematic review and meta-analysis.Scientific reports · 2021Pooled it
- Evaluating the efficacy of treatment options for anal intraepithelial neoplasia: a systematic review.International journal of colorectal disease · 2021Pooled it
- A systematic review of immunogenicity, clinical efficacy and safety of human papillomavirus vaccines in people living with the human immunodeficiency virus.Human vaccines & immunotherapeutics · 2020Pooled it
- Comparison of different human papillomavirus (HPV) vaccine types and dose schedules for prevention of HPV-related disease in females and males.The Cochrane database of systematic reviews · 2019Pooled it
- 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
- Nonavalent HPV vaccine to prevent recurrent anal or vulvar high-grade squamous intraepithelial lesions (VIVA trial): A randomized, double-blind, placebo-controlled trial.International journal of cancer · 2026Trial
- Human Papillomavirus Vaccination Prior to Loop Electroexcision Procedure Does Not Prevent Recurrent Cervical High-grade Squamous Intraepithelial Lesions in Women Living With Human Immunodeficiency Virus: A Randomized, Double-blind, Placebo-controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Effectiveness of the Quadrivalent HPV Vaccine in Preventing Anal ≥ HSILs in a Spanish Population of HIV+ MSM Aged > 26 Years.Viruses · 2021Trial
- Oral and systemic HPV antibody kinetics post-vaccination among HIV-positive and HIV-negative men.Vaccine · 2019Trial
- Dynamics of anal HPV infection after 9vHPV vaccination in men who have sex with men (MSM) with HIV: A prospective, controlled cohort study.Human vaccines & immunotherapeutics · 2026Article
- [Vaccine prevention of HPV-associated diseases].Dermatologie (Heidelberg, Germany) · 2026Review
- Randomised phase III trials of cancer prevention drugs: a systematic review and prediction of trial success.ESMO open · 2026Review
- Anal High-Grade Squamous Intraepithelial Lesions in People Living with HIV: A Systematic Review of Treatment Outcomes.Cancers · 2026Review
- Long-term intraanal HPV16 infection in men having sex with men with HIV: Persistence or reinfection?Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Evaluation of Anal Cancer Screening Among 18-to-34-Year-Old Men Who Have Sex With Men Living With HIV Over a 10-Year Period.Open forum infectious diseases · 2026Article
- Incidence and burden of anal cancer-time to fight the growing disparities.ESMO gastrointestinal oncology · 2026Review
- Closing the Gap: HPV Vaccination and Head and Neck Cancer Prevention.Current oncology reports · 2026Review
21 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 11 institutions in 2 countries.
Funding
Abstract
Background: Adults living with human immunodeficiency virus (HIV) are at increased risk for anal and oropharyngeal cancer caused by human papillomavirus (HPV). The efficacy of HPV vaccines in this population is unknown. Methods: In this phase 3, double-blind, randomized, controlled trial, we assigned HIV-infected adults aged ≥27 years to the quadrivalent HPV (types 6, 11, 16, 18) vaccine or placebo (1:1) stratified by sex and presence of anal high-grade squamous intraepithelial lesions on biopsy (bHSIL). The primary endpoint was vaccine efficacy against incident persistent anal infection with quadrivalent vaccine types or single detection at the final visit that were not present at baseline. Secondary endpoints included vaccine efficacy for anal bHSIL after week 52, persistent oral HPV infection. Results: A total of 575 participants were randomized. The Data and Safety Monitoring Board stopped the study early due to futility. Vaccine efficacy was 22% (95.1% confidence interval [CI], -31%, 53%) for prevention of persistent anal infection or single detection at the final visit, 0% (95% CI -44%, 31%) for improving bHSIL outcomes and 88% (95.1% CI 2%, 98%) for preventing persistent oral HPV infection, but was 32% (95.1% CI -80%, 74%) for 6-month persistent oral HPV infection or single detection at the final visit. Conclusions: These results do not support HPV vaccination of HIV-infected adults aged ≥27 years to prevent new anal HPV infections or to improve anal HSIL outcomes. However, our data suggest a role for prevention of oral HPV infections, but this finding should be confirmed in future studies. Clinical Trials Registration: NCT01461096.
Indexed as
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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.