US EPA

1761752 

Journal Article 

Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16, 18 Vaccine For the Prevention of Genital Warts in Males 

Garnock-Jones, KP; Giuliano, AR 

2011 

Yes 

Drugs
ISSN: 0012-6667
EISSN: 1179-1950 

71 

5 

591-602 

21443282 

WOS:000289752700006 

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.