HPV Vaccine Beneficial in Men Who Have Sex With Men

Larry M. Baddour, MD


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In This Article

Abstract and Introduction


A quadrivalent HPV vaccine significantly reduced the rate of anal intraepithelial neoplasia in this high-risk population.


The incidence of anal cancer has been increasing in recent years. Often caused by infection with human papillomavirus (HPV), particularly types 16 and 18, this cancer is preceded by high-grade anal intraepithelial neoplasia (AIN; grade 2 or 3). Might the quadrivalent HPV vaccine, which is protective against high-grade cervical intraepithelial neoplasia in women, also protect against AIN? To find out, investigators conducted a multinational, double-blind, controlled vaccine trial in men who have sex with men — a group at high risk for HPV infection and its oncologic complications. The trial was partially funded by the vaccine manufacturer.

A total of 602 men, aged 16 to 26 and HIV negative at the time of enrollment, were randomized to receive three doses of quadrivalent HPV vaccine or placebo. Serum specimens for HPV serologic testing were obtained at baseline and at month 7; detailed anal examinations occurred at baseline and over the next 36 months.

No cases of anal cancer occurred, which was expected because of the relatively young age of trial participants. Vaccine efficacy against AIN associated with the four vaccine HPV types — 6, 11, 16, and 18 — was 50.3% (95% confidence interval, 25.7–67.2) in the intent-to-treat population and 77.5% (95% CI, 39.6–93.3) in the per-protocol population. Efficacy against persistent anal infection with a vaccine HPV type was 59.4% (95% CI, 43.0–71.4) and 94.9% (95% CI, 80.4–99.4), respectively. Adverse events were mostly local injection-site reactions and were similar between the two groups; no serious vaccine-related adverse events or deaths were reported.


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