Quadrivalent HPV Vaccine Safe and Effective in Men

NEW YORK (Reuters Health) Jul 22 - The quadrivalent human papillomavirus (HPV) vaccine (Gardasil) prevents infection and disease in men, according to data presented today at AIDS 2010 in Vienna.

In fact, the efficacy data were so good that the U.S. Food and Drug Administration stopped the trial early so that men in the placebo group could get the vaccine, presenter Dr. Heiko Jessen from Berlin, Germany, told Reuters Health.

Infection with oncogenic HPV can cause cancers of the penis, anus, and head and neck in men, and AIDS substantially increases the risk of HPV-related invasive cancers. Earlier this year the US Centers for Disease Control and Prevention issued a "permissive recommendation" for HPV vaccination in males ages 9 through 26. (See Reuters Health reports of Jan 4, 2010 and Jul 31, 2009.)

The randomized, double-blind, placebo-controlled trial started out with more than 4000 healthy men aged 16 to 26 years from 18 countries. The per-protocol analysis, reported here, involved 1400 men (including 200 men who have sex with men) in each arm followed for 3 years, Dr. Jessen said.

As noted in their meeting abstract, the researchers detected 3 external genital lesions related to HPV types 6, 11, 16 or 18 in the vaccine arm and 31 in the placebo arm - primarily condylomata acuminate - for an efficacy of 90.4%.

Efficacy against HPV vaccine types was 85.6%, and against HPV DNA detection at any time was 44.7%.

"People who are immune may still have HPV DNA," Dr. Jessen said, but the significance is unknown.

There were no cases of penile, perianal or perineal intraepithelial neoplasia, but one wouldn't expect these in young healthy men during a short follow-up trial, he added. The research team will continue to follow the participants.

"For now it makes sense to give the HPV vaccine to boys and men ages 9 to 26," Dr. Jessen said, but his group intends to examine its efficacy in older men as well, particularly in men who have sex with men, who are at higher risk for HPV-related malignancy.

There were no serious vaccine-related adverse experiences, he added.