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
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
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DOI：
10.2165/11206820-000000000-00000
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发表时间：
2011-01-01
期刊：
影响因子：
11.5
通讯作者：
Romanowski, Barbara
中科院分区：
文献类型：
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作者：
McKeage, Kate;Romanowski, Barbara
AS 04佐剂人乳头瘤病毒（HPV）16/18疫苗（Cervarixe（R））是一种非感染性重组疫苗，使用纯化的病毒样颗粒（VLP）生产，诱导强烈的免疫原性应答，引发高水平的抗L1 VLP抗体，其持续水平明显高于自然感染时观察到的水平。疫苗佐剂（AS 04）由单磷酰脂质A组成，可增强细胞和体液免疫应答，吸附于氢氧化铝上。该疫苗适用于预防10岁以下女性中与某些致癌HPV类型有因果关系的癌前宫颈病变和宫颈癌。在6个月内以三剂方案接种含AS 04佐剂的HPV 16/18疫苗可产生高免疫原性应答，并对宫颈上皮内瘤变和与高危致癌HPV类型有因果关系的感染具有高度保护作用。在设计良好的临床试验中，年龄在15-25岁的年轻女性中，HPV 16/18血清阴性，14种HPV高危型DNA阴性，高水平的免疫原性和保护作用持续长达8.4年的随访期。针对HPV 16/18感染的高和持久免疫原性也已在HPV疫苗类型血清阴性的老年和年轻女性（10-55岁）中得到证实。在HPV 16/18血清阴性和DNA阴性的18-45岁女性中，含AS 04佐剂的HPV 16/18疫苗比四价HPV疫苗引起更大的免疫原性应答。含AS 04佐剂的HPV 16/18疫苗可对某些非疫苗高危HPV类型提供交叉保护。第四剂疫苗接种后，引发了快速而强烈的回忆性体液免疫应答。含AS 04佐剂的HPV 16/18疫苗通常耐受性良好，药物经济学分析表明，当疫苗接种计划与筛查计划结合运行时，可能会带来公共卫生效益和成本效益。因此，含AS 04佐剂的HPV 16/18疫苗可预防与某些致癌HPV类型相关的宫颈疾病，从而降低癌前宫颈病变的负担，并很可能降低宫颈癌的负担。
The AS04-adjuvanted human papillomavirus (HPV) 16/18 vaccine (Cervarixe (R)) 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.