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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…