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Study done on "men who have sex with men"
 
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Published: 12 years ago
 
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Study done on "men who have sex with men"


 

 

HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia

Background

The rate of anal cancer is increasing among both women and men, particularly men who have sex with men. Caused by infection with human papillomavirus (HPV), primarily HPV type 16 or 18, anal cancer is preceded by high-grade anal intraepithelial neoplasia (grade 2 or 3). We studied the safety and efficacy of quadrivalent HPV vaccine (qHPV) against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 infection in men who have sex with men.

Methods

In a substudy of a larger double-blind study, we randomly assigned 602 healthy men who have sex with men, 16 to 26 years of age, to receive either qHPV or placebo. The primary efficacy objective was prevention of anal intraepithelial neoplasia or anal cancer related to infection with HPV-6, 11, 16, or 18. Efficacy analyses were performed in intention-to-treat and per-protocol efficacy populations. The rates of adverse events were documented.

Conclusions

Use of the qHPV vaccine reduced the rates of anal intraepithelial neoplasia, including of grade 2 or 3, among men who have sex with men. The vaccine had a favorable safety profile and may help to reduce the risk of anal cancer. (Funded by Merck and the National Institutes of Health; ClinicalTrials.gov number, NCT00090285.)

 

Supported by grants from Merck and the National Institutes of Health (NIH/NCRR M01-RR-00079 and UL1 RR024131, to the University of California, San Francisco General Clinical Research Center, where some participants were studied).

Dr. Coutlee reports receiving funding through his institution from Merck Sharp & Dohme and providing expert testimony for GlaxoSmithKline and Qiagen. Dr. Ferris reports receiving funding through his institution, consulting fees and honoraria, and travel support from Merck Sharp & Dohme, serving as a board member for Merck Sharp & Dohme, and receiving consulting fees and honoraria from GlaxoSmithKline. Dr. Giuliano reports serving as a board member and consultant for and receiving grant support and honoraria from Merck Sharp & Dohme. Dr. Goldstone reports receiving grant support, consulting fees, and travel support from Merck Sharp & Dohme, serving as a consultant for and receiving grants and honoraria from Qiagen, receiving grants and travel support from the AIDS Malignancy Consortium, and receiving honoraria for the development of educational presentations and reimbursement for travel, accommodations, and meeting expenses from the American Social Health Association. Dr. Jessen reports receiving travel support from Merck Sharp & Dohme. Dr. Moreira reports receiving grant support through his institution, consulting fees, honoraria, travel support, and fees for review activities from Merck Sharp & Dohme and serving as a board member and consultant for Merck Sharp & Dohme. Dr. Palefsky reports receiving grant support through his institution, travel support, and fees for review activities through his institution from Merck Sharp & Dohme, serving as a board member and consultant and providing expert testimony for Merck Sharp & Dohme and receiving fees for these activities through his institution, serving as a member of the scientific advisory board of Pharmajet and receiving consulting fees for this activity through his institution, and serving as a member of the scientific advisory board of Aura Biosciences, for which he has received stock options. Dr. Stoler reports receiving consulting fees and honoraria through his institution from Merck Sharp & Dohme and serving as a consultant for Roche, Gen Probe, Qiagen, MTM Laboratories, Ventana, and Becton Dickinson. Drs. Garner, Guris, Haupt, Marshall, and Vuocolo and Mr. Radley report being employees of Merck Sharp & Dohme and owning stock or stock options. No other potential conflict of interest relevant to this article was reported.

 

 
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