Trial reportJournal of acquired immune deficiency syndromes (1999)2012
Sexual risk behaviors, circumcision status, and preexisting immunity to adenovirus type 5 among men who have sex with men participating in a randomized HIV-1 vaccine efficacy trial: step study.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Circumcision for HIV Prevention in Men Who Have Sex With Men: An Updated Meta-Analysis.Journal of acquired immune deficiency syndromes (1999) · 2026Pooled it
- Circumcision to prevent HIV and other sexually transmitted infections in men who have sex with men: a systematic review and meta-analysis of global data.The Lancet. Global health · 2019Pooled it
- Risk behavior among women enrolled in a randomized controlled efficacy trial of an adenoviral vector vaccine to prevent HIV acquisition.AIDS (London, England) · 2013Trial
- Editorial: CD4+ T cells in HIV: A Friend or a Foe?Frontiers in immunology · 2023Article
- Vaccine-associated enhanced disease in humans and animal models: Lessons and challenges for vaccine development.Frontiers in microbiology · 2022Review
- To clot or not to clot? Ad is the question-Insights on mechanisms related to vaccine-induced thrombotic thrombocytopenia.Journal of thrombosis and haemostasis : JTH · 2021Article
- Understanding Post Entry Sorting of Adenovirus Capsids; A Chance to Change Vaccine Vector Properties.Viruses · 2021Review
- Article
- Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2019Article
- Voluntary medical male circumcision and HIV infection among men who have sex with men: Implications from a systematic review.SAGE open medicine · 2019Review
- Conserved HIV Epitopes for an Effective HIV Vaccine.Journal of clinical & cellular immunology · 2017Article
- Promise and problems associated with the use of recombinant AAV for the delivery of anti-HIV antibodies.Molecular therapy. Methods & clinical development · 2016Review
- New prospects for a preventive HIV-1 vaccine.Journal of virus eradication · 2015Article
- HIV-1 vaccines: challenges and new perspectives.Human vaccines & immunotherapeutics · 2014Review
- Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention.Human vaccines & immunotherapeutics · 2014Review
- Article
- Novel directions in HIV-1 vaccines revealed from clinical trials.Current opinion in HIV and AIDS · 2013Review
- Lessons learned from HIV vaccine clinical efficacy trials.Current HIV research · 2013Review
- Preparing for the unexpected: the pivotal role of social and behavioral sciences in trials of biomedical HIV prevention interventions.Journal of acquired immune deficiency syndromes (1999) · 2013Article
- Does participation in an HIV vaccine efficacy trial affect risk behaviour in South Africa?Vaccine · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
Abstract
backgroundThe Step Study found that men who had sex with men (MSM) who received an adenovirus type 5 (Ad5) vector-based vaccine and were uncircumcised or had prior Ad5 immunity, had a higher HIV incidence than MSM who received placebo. We investigated whether differences in HIV exposure, measured by reported sexual risk behaviors, may explain the increased risk.
methodsAmong 1764 MSM in the trial, 726 were uncircumcised, 994 had prior Ad5 immunity, and 563 were both uncircumcised and had prior Ad5 immunity. Analyses compared sexual risk behaviors and perceived treatment assignment among vaccine and placebo recipients, determined risk factors for HIV acquisition, and examined the role of insertive anal intercourse in HIV risk among uncircumcised men.
resultsFew sexual risk behaviors were significantly higher in vaccine versus placebo recipients at baseline or during follow-up. Among uncircumcised men, vaccine recipients at baseline were more likely to report unprotected insertive anal intercourse with HIV-negative partners (24.9% vs. 18.1%; P = 0.03). Among uncircumcised men who had prior Ad5 immunity, vaccine recipients were more likely to report unprotected insertive anal intercourse with partners of unknown HIV status (46.0% vs. 37.8%; P = 0.05). Vaccine recipients remained at higher risk of HIV infection compared with placebo recipients (hazard ratio = 2.8; 95% confidence interval, 1.2-6.8) controlling for potential confounders.
conclusionsThese analyses do not support a behavioral explanation for the increased HIV infection rates observed among uncircumcised men in the Step Study. Identifying biologic mechanisms to explain the increased risk is a priority .
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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.