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Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16, 18 Vaccine

For the Prevention of Genital Warts in Males

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Abstract

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.

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Acknowledgements and Disclosures

The manuscript was reviewed by: K. Kohl, Division of Global Migration and Quarantine, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA; A. Moore, Arlington Center for Dermatology, Department of Dermatology, Baylor University Medical Center, Dallas, Texas, USA, and Department of Dermatology, University of Texas Medical Branch at Galveston, Galveston, Texas, USA.

The 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.

A. Giuliano is on the Speaker’s Bureau of Merck and Co, Inc., and is a consultant to Merck and Co, Inc.

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Authors and Affiliations

  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Karly P. Garnock-Jones

  2. Department of Cancer Epidemiology and Genetics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA

    Anna R. Giuliano

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  1. Karly P. Garnock-Jones
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  2. Anna R. Giuliano
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Correspondence to Karly P. Garnock-Jones.

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Garnock-Jones, K.P., Giuliano, A.R. Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16, 18 Vaccine. Drugs 71, 591–602 (2011). https://doi.org/10.2165/11205980-000000000-00000

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