Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Drugs. 2011 Mar 5;71(4):465-88. doi: 10.2165/11206820-000000000-00000.
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 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 16/18 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 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 programmes are run in conjunction with screening programmes. 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.
AS04 佐剂人乳头瘤病毒（HPV）16/18 疫苗（佳达修®）是一种非传染性重组疫苗，使用纯化的病毒样颗粒（VLPs）制成，可诱导强烈的免疫应答，产生高水平的抗 L1 VLP 抗体，其水平明显高于自然感染所观察到的水平。疫苗佐剂（AS04）由单磷酰脂质 A 组成，可增强细胞和体液免疫应答，吸附在氢氧化铝上。该疫苗适用于预防女性 10 岁及以上与某些致癌 HPV 类型相关的癌前宫颈病变和宫颈癌。在 6 个月内分 3 剂接种 AS04 佐剂 HPV 16/18 疫苗可引发高度免疫应答，对宫颈上皮内瘤变和与高危致癌 HPV 类型相关的感染具有高度保护作用。在设计良好的临床试验中，15-25 岁的年轻女性 HPV16/18 血清阴性且对 14 种 HPV 高危型 DNA 阴性，在长达 8.4 年的随访期间，免疫原性和保护水平持续保持较高水平。在年龄较大和较小的女性（10-55 岁）中，针对 HPV16/18 的感染也显示出较高和持久的免疫原性，这些女性对疫苗 HPV 类型血清阴性。在血清阴性且 HPV16/18 DNA 阴性的 18-45 岁女性中，AS04 佐剂 HPV 16/18 疫苗比四价 HPV 疫苗引发更大的免疫应答。AS04 佐剂 HPV 16/18 疫苗对某些非疫苗高危 HPV 类型具有交叉保护作用。接种第四剂疫苗后，可迅速引发强烈的记忆体液免疫应答。AS04 佐剂 HPV 16/18 疫苗通常具有良好的耐受性，药物经济学分析表明，在与筛查计划相结合开展疫苗接种计划时，具有公共卫生效益和成本效益的潜力。因此，AS04 佐剂 HPV 16/18 疫苗可预防与某些致癌 HPV 类型相关的宫颈癌，从而降低癌前宫颈病变的负担，并且很可能降低宫颈癌的发病率。
