Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], 'the HPV vaccine', prevented 90 per cent of external genital lesions, including genital warts caused by HPV types 6, 11, 16 and 18 in a phase-III study in men aged 16 to 26 who were not infected with one or more of the four vaccine HPV types through one month post dose three. These data, presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference taking place in Nice, France, are the first on the efficacy of the HPV vaccine in males.
"Almost everyone will acquire an HPV infection in their lifetime and these infections cause a significant burden of disease in Canada," said Dr François Coutlée, professor at the University of Montreal, study investigator and Clinical Researcher at the Molecular Virology Laboratory, CHUM - Hôpital Notre-Dame. "In fact, HPV diseases are on the rise among Canadian men so I am encouraged by these new results showing the efficacy of the HPV vaccine in males against diseases caused by HPV types 6, 11, 16 and 18." The HPV vaccine is not indicated for males. It was approved in Canada in 2006 for females nine through 26 years of age for the prevention of cervical cancer, vulvar cancer, vaginal cancer, their precancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18. The HPV vaccine reduced external genital lesions in males by 90 per cent
This placebo-controlled study was designed to determine the efficacy of the HPV vaccine in males against HPV 6/11/16/18-related external genital lesions, a composite endpoint that included: 1) genital warts (condyloma), 2) penile/perineal/perianal intraepithelial neoplasia (or PIN; lesions that can be pre-cursors to cancer) and 3) penile/perineal/perianal cancer. The study evaluated 3,400 heterosexual males 16 through 23 years of age and 600 men having sex with men 16 to 26 years of age. Participants were randomized in a 1:1 ratio to receive either the vaccine or placebo at day one, two months and six months, with 36 months of planned follow-up from day one. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners.
New study on males shows Gardasil reduced HPV-related diseases / 2 In the study, the HPV vaccine was 90.4 per cent effective at reducing external genital lesions (three cases in the vaccine group vs. 31 cases in placebo group; 95 per cent CI: 69.2, 98.1, p-value <0.001). The three cases seen among those vaccinated with the HPV vaccine were all cases of genital warts, resulting in the vaccine being 89.4 per cent effective in preventing genital warts (95 per cent CI: 65.5, 97.9). For penile/perineal/perianal intraepithelial neoplasia or PIN, there were zero cases in the vaccine group vs. three cases of PIN 1 or PIN 2/3 in the placebo group. There were no cases of penile/perineal/perianal cancer in either the vaccine or placebo group.
Most people who get HPV (of any type) never develop any symptoms or health problems. But some types of HPV can cause genital warts. Other types can cause penile cancer or anal cancer. The types of HPV that can cause genital warts are not the same as the types that can cause penile or anal cancer.
A recent Canadian report estimated the number of new cases (both men and women) of ano-genital warts at 41,450 per year.1 In the year 2003-04, there were 491 new cases of anal cancer (203 in men, 288 in women) and 142 new cases of penile cancer in Canada.2
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