Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial
Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial
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DOI：
10.1016/s0140-6736(04)17398-4
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发表时间：
2004-11-13
期刊：
影响因子：
168.9
通讯作者：
Dubin, G
中科院分区：
文献类型：
--
作者：
Harper, DM;Franco, EL;Dubin, G
背景针对最常见的致癌性人乳头瘤病毒（HPV）类型HPV-16和HPV-18的疫苗接种可以预防全球高达70%的宫颈癌的发生。我们进行了一项随机、双盲、对照试验，以评估二价HPV-16/18 L1病毒样颗粒疫苗预防这两种病毒类型的偶发性和持续性感染、相关宫颈细胞学异常、和癌前病变。方法我们随机选择1113名15-在北美和巴西，年龄25岁的受试者按照0个月、1个月和6个月的时间表接受三剂用AS 04佐剂或安慰剂配制的疫苗。妇女进行了评估HPV感染的宫颈细胞学和自我获得的宫颈阴道样本长达27个月，疫苗的安全性和immunogenicity.Findings在根据协议的分析，疫苗的有效性为91.6%（95%CI 64.5-98.0）对偶发感染和100%对持续感染（47.0-100）与HPV-16/18。在意向治疗分析中，疫苗对HPV-16/18持续性宫颈感染的有效性为95.1%（63.5-99.3），对HPV-16/18感染相关的细胞学异常的有效性为92.9%（70.0-98.3）。该疫苗是普遍安全的，耐受性好，和高immunogeneic.Interpretation二价HPV疫苗是有效的预防事件和持续性的HPV-16和HPV-18的宫颈感染，以及相关的细胞学异常和病变。接种预防此类感染的疫苗可大大降低宫颈癌的发病率。
Background Vaccination against the most common oncogenic human papillomavirus (HPV) types, HPV-16 and HPV-18, could prevent development of up to 70% of cervical cancers worldwide. We did a randomised, double-blind, controlled trial to assess the efficacy, safety, and immunogenicity of a bivalent HPV-16/18 L1 virus-like particle vaccine for the prevention of incident and persistent infection with these two virus types, associated cervical cytological abnormalities, and precancerous lesions.Methods We randomised 1113 women between 15-25 years of age to receive three doses of either the vaccine formulated with AS04 adjuvant or placebo on a 0 month, 1 month, and 6 month schedule in North America and Brazil. Women were assessed for HPV infection by cervical cytology and self-obtained cervicovaginal samples for up to 27 months, and for vaccine safety and immunogenicity.Findings In the according-to-protocol analyses, vaccine efficacy was 91.6% (95% CI 64.5-98.0) against incident infection and 100% against persistent infection (47.0-100) with HPV-16/18. In the intention-to-treat analyses, vaccine efficacy was 95.1% (63.5-99.3) against persistent cervical infection with HPV-16/18 and 92.9% (70.0-98.3) against cytological abnormalities associated with HPV-16/18 infection. The vaccine was generally safe, well tolerated, and highly immunogenic.Interpretation The bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.