AS04-adjuvanted human papillomavirus (HPV) types 16 and 18 vaccine (Cervarix®): A review of its use in the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic HPV types

The AS04-adjuvanted human papillomavirus (HPV) 1618 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 aluminium 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 1618 vaccine administered 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 1525 years who were HPV 1618 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 1618 has also been demonstrated in older and younger females (aged 1055 years) who were seronegative for vaccine HPV types. The AS04-adjuvanted HPV 1618 vaccine elicited a greater immunogenic response than the quadrivalent HPV vaccine in women aged 1845 years who were seronegative and DNA negative for HPV 1618. The AS04-adjuvanted HPV 1618 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 1618 vaccine is generally well tolerated, and pharmacoeconomic analyses have demonstrated the potential for public health benefits and cost effectiveness when vaccination programmes are run in conjunction with screening programmes. Thus, the AS04-adjuvanted HPV 1618 vaccine prevents cervical disease associated with certain oncogenic HPV types, thereby reducing the burden of premalignant cervical lesions and, very likely, cervical cancer. © 2011 Adis Data Information BV. All rights reserved.