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Spotlight on AS04-Adjuvanted Human Papillomavirus (HPV) Types 16 and 18 Vaccine (Cervarix®)

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Abstract

The AS04-adjuvanted human papillomavirus (HPV) 16/18 vaccine (Cervarix®) is a noninfectious recombinant vaccine produced using purified virus-like particles (VLPs) that induce a strong immunogenic response eliciting high levels of anti-L1 VLP antibodies that persist at levels markedly greater than those observed with natural infection. The vaccine adjuvant (AS04) is composed of monophosphoryl-lipid A, which enhances cellular and humoral immune response, adsorbed to aluminum hydroxide. The vaccine is indicated for the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic HPV types in females aged ≥10 years.

The AS04-adjuvanted HPV 16/18 vaccine, administered via an intramuscular injection in a three-dose schedule over 6 months, elicits a high immunogenic response and is highly protective against cervical intraepithelial neoplasia and infection causally related to high-risk oncogenic HPV types. In well designed clinical trials in young women aged 15–25 years who were HPV 16/18 seronegative and DNA negative to 14 HPV high-risk types, high levels of immunogenicity and protection were sustained for follow-up periods of up to 8.4 years. High and persistent immunogenicity against infection with HPV 16/18 has also been demonstrated in older and younger females (aged 10–55 years) who were seronegative for vaccine HPV types. The AS04-adjuvanted HPV 16/18 vaccine elicited a greater immunogenic response than the quadrivalent HPV vaccine in women aged 18–45 years who were seronegative and DNA negative for HPV 16/18. The AS04-adjuvanted HPV 16/18 vaccine confers cross protection against certain non-vaccine, high-risk HPV types. A rapid and strong anamnestic humoral immune response was elicited following a fourth dose of the vaccine. The AS04-adjuvanted HPV 16/18 vaccine is generally well tolerated, and pharmacoeconomic analyses have demonstrated the potential for public health benefits and cost effectiveness when vaccination programs are run in conjunction with screening programs. Thus, the AS04-adjuvanted HPV 16/18 vaccine prevents cervical disease associated with certain oncogenic HPV types, thereby reducing the burden of premalignant cervical lesions and, very likely, cervical cancer.

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Acknowledgments and Disclosures

The full text article[41] from which this spotlight was derived was reviewed by: N. De Carvalho, Federal University of Parana, Curitiba, Brazil; M. Diaz, Unit of Infections and Cancer, Catalan Institute of Oncology, Barcelona, Spain; J. Garcia-Sicilia, Department of Paediatrics, La Paz Hospital, Madrid, Spain.

The manufacturer of the agent under review was offered an opportunity to comment on the original article[41] during the peer review process; changes based on any comments received were made on the basis of scientific and editorial merit. The preparation of the original article and this spotlight was not supported by external funding.

Dr Romanowski has participated in advisory boards, provided consultancies and lectures, and undertaken HPV vaccine-related research, for which financial support from GlaxoSmithKline Biologicals has been received by her academic institution or corporation.

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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

    Kate McKeage

  2. Division of Infectious Diseases, University of Alberta, Edmonton, Alberta, Canada

    Barbara Romanowski

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  1. Kate McKeage
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  2. Barbara Romanowski
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Correspondence to Kate McKeage.

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Adapted and reproduced from the original article published in Drugs 2011; 71 (4): 465–488

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McKeage, K., Romanowski, B. Spotlight on AS04-Adjuvanted Human Papillomavirus (HPV) Types 16 and 18 Vaccine (Cervarix®). BioDrugs 25, 265–269 (2011). https://doi.org/10.2165/11206830-000000000-00000

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