Quadrivalent human papillomavirus (HPV) types 6, 11, 16, 18 vaccine: for the prevention of genital warts in males.

摘要

The quadrivalent HPV types 6, 11, 16, 18 vaccine (Gardasil(R)) is a recombinant vaccine comprising purified virus-like particles derived from the L1 capsid proteins of HPV types 6, 11, 16 and 18. The vaccine was highly immunogenic. Geometric mean titres (GMTs) and seroconversion rates for all four HPV types at month 7 in males aged 10-15 years were noninferior to those in females aged 16-23 years, and those in males aged 9-15 years were noninferior to those in females aged 9-15 years. In addition, GMTs and seroconversion rates in males aged 16-26 years receiving the vaccine were higher than those receiving amorphous aluminium hydroxyphosphate sulfate adjuvant (AAHS) control. The quadrivalent HPV vaccine was significantly more effective than AAHS control at decreasing the incidence of HPV 6-, 11-, 16- or 18-related external genital lesions (primary endpoint) in a randomized, double-blind, placebo-controlled, multicentre study in males aged 16-26 years. The most common clinical endpoint was HPV 6- and 11-related condyloma; efficacy was robust against these lesions. The vaccine is also expected to be protective against genital warts in males aged 9-15 years, as the immune response in males of this age group was noninferior to that in males aged 16-26 years. The quadrivalent HPV vaccine was generally well tolerated in males aged 9-26 years. The most common adverse events reported were injection-site related, and most of these were of mild to moderate severity.