WHITEHOUSE STATION, N.J. A vaccine made by Merck for preventing human papillomavirus works for preventing anal warts and cancer in men who have sex with men ages 16 to 26 years, according to results of a phase-3 trial announced Wednesday.
The drug maker presented data from the study of Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18], recombinant) at the conference of the European Research Organization on Genital Infection and Neoplasia in Monte Carlo, Monaco.
“We are excited to learn about the potential of Gardasil to help prevent HPV and HPV-related cancers and disease in both men and women,” Merck Research Labs executive director Richard Haupt stated.
For the study, researchers administered Gardasil or placebo to 598 men who have sex with men, a general term used by many clinicians for men who may give themselves such labels as gay, bisexual or otherwise or maybe closeted. This group is considered to be at high risk of anal HPV infection. Cases of infection and anal cancer were counted after the seventh month, with an average follow-up of two and a half years. In the end, the vaccine prevented 77.5% of infections and cancers. Twenty-four men who took placebo were diagnosed with HPV infection, compared with five who took the vaccine; there were no cases of anal cancer in either group.
The vaccine has approval from the Food and Drug Administration for females ages 9 to 26 years to prevent cervical, vulvar and vaginal cancers, genital warts and lesions caused by HPV. It also has approval for use in boys and men ages 9 to 26 years for prevention of genital warts.