The quadrivalent HPV types 6, 11, 16, 18 vaccine (Gardasil ® ) 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.Correspondence: Karly P. Garnock-Jones, Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand. demail@adis.co.nz.
DisclosuresThe preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
HHS Public Access
Author manuscriptDrugs. Author manuscript; available in PMC 2015 November 11.
Published in final edited form as:Drugs. 2011 March 26; 71(5): 591-602. doi:10.2165/11205980-000000000-00000.
Author Manuscript Author ManuscriptAuthor Manuscript
Author ManuscriptFeatures and properties of the quadrivalent human papillomavirus (HPV) types 6, 11, 16, 18 vaccine (Gardasil®)
Featured indicationPrevention of genital warts (condyloma acuminata) caused by infection with HPV types 6 and 11 in males aged 9-26 y
Vaccine compositionVirus-like particles (VLPs) derived from the L1 capsid proteins of HPV types 6, 11, 16 and 18Formulated with a proprietary amorphous aluminium hydroxyphosphate sulfate adjuvant (225 μg per dose)
Dosage and administrationRoute of administration Intramuscular injection Dose 0.5 mL (containing 20, 40, 40 and 20 μg of VLPs for HPV types 6, 11, 16 and 18, respectively)Administration schedule Three-dose regimen; injections at months 0, 2 and 6Most common adverse events (≥5% of males aged 9-26 years receiving the quadrivalent HPV vaccine)Injectio...