Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine

Brown DR; Fife KH; Wheeler CM; Koutsky LA; Lupinacci LM; Railkar R; Suhr G; Barr E; Dicello A; Li W; Smith JF; Tadesse A; Jansen KU

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Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine

机译：早期评估人乳头瘤病毒16型L1病毒样颗粒疫苗的功效

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A post hoc analysis was performed using combined data from two Phase I tolerability/immunogenicity studies of monovalent human papillomavirus type 11 (HPV11) or HPV16 L1 virus-like particle (VLP) vaccines. The goal was to determine if the HPV16 L1 VLP vaccine protected against HPV16 infection. Vaccine or placebo was given at 0, 2 and 6 months. HPV16 infection was defined by positive polymerase chain reaction (PCR) results following vaccination. The incidence of HPV infection was observed to be 0 cases per 100 person-years at risk in the vaccine group, and 5 cases per 100 person-years at risk in the control group. These results support the institution of larger efficacy trials for HPV L1 VLP vaccines.

机译：使用来自两项单价11型人乳头瘤病毒（HPV11）或HPV16 L1病毒样颗粒（VLP）疫苗的I期耐受性/免疫原性研究的组合数据进行事后分析。目的是确定HPV16 L1 VLP疫苗是否能抵抗HPV16感染。在0、2和6个月时给予疫苗或安慰剂。疫苗接种后通过阳性聚合酶链反应（PCR）结果确定HPV16感染。在疫苗组中，HPV感染的发生率每100人年有0例，有风险，在对照组中每100人年有5例。这些结果支持对HPV L1 VLP疫苗进行更大的功效试验。

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《Vaccine》 |2004年第22期|共7页
作者
Brown DR; Fife KH; Wheeler CM; Koutsky LA; Lupinacci LM; Railkar R; Suhr G; Barr E; Dicello A; Li W; Smith JF; Tadesse A; Jansen KU;
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正文语种 eng
中图分类卫生标准、卫生检查、医药管理;
关键词
Adolescent; Adult; Antibodies; Viral analysis biosynthesis; DNA Primers; Dose-Response Relationship; Immunologic; Endpoint Determination; Female; Follow-Up Studies; Human; Papillomavirus Infections immunology prevention amp; control; Papillomavirus; Human immunology; Radioimmunoassay; Reverse Transcriptase Polymerase Chain Reaction; Specimen Handling; Time Factors; Vaccines; DNA adverse effects immunology; Viral Vaccines adverse effects immunology;

机译：青少年;成人;抗体;病毒分析生物合成;DNA引物;剂量反应关系;免疫学;终点测定;女性;随访研究;人;乳头瘤病毒感染的免疫学预防和控制;乳头瘤病毒;人免疫学;放射免疫测定;逆转录酶聚合酶链反应反应;标本处理;时间因素;疫苗;DNA不良反应免疫学;病毒疫苗不良反应免疫学;

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专利

1. Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine [J] . Brown DR, Fife KH, Wheeler CM, Vaccine . 2004,第21a22期

机译：早期评估人乳头瘤病毒16型L1病毒样颗粒疫苗的功效
2. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6|[sol]|11|[sol]|16|[sol]|18 L1 virus-like particle vaccine through 5 years of follow-up [J] . L L Villa, R L R Costa, C A Petta, British Journal of Cancer . 2006,第11期

机译：通过五年的随访，预防性的四价人乳头瘤病毒6 | [sol] | 11 | [sol] | 16 | [sol] | 18 L1病毒样颗粒疫苗的高持续疗效
3. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. [J] . Villa LL, Costa RL, Petta CA, The lancet oncology . 2005,第5期

机译：预防性四价人类乳头瘤病毒（6、11、16和18型）L1病毒样颗粒疫苗在年轻女性中：一项随机的双盲安慰剂对照多中心II期疗效试验。
4. Structural Characterization of L1 Virus-Like Particles Used as Antigens in Cervarix~(TM) , the HPV-16 and HPV-18 Vaccine against Cervical Cancer [C] . M. Deschuyteneer, A. Miseur Microscopy and microanalysis.;Microscopy and microanalysis. . -1

机译：用于宫颈癌的Cervarix〜（TM），HPV-16和HPV-18疫苗中用作抗原的L1病毒样颗粒的结构表征
5. Production and Characterization of Chimeric Human Papillomavirus L1 Virus-Like Particles for Use as a Contraceptive Vaccine [D] . Brown Jordan, Thomas. 2020

机译：嵌合人乳头瘤病毒L1病毒样颗粒的生产和表征用作避孕疫苗
6. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up [O] . L L Villa, R L R Costa, C A Petta, 2006

机译：通过5年的随访预防性的四价人乳头瘤病毒6/11/16/18型L1病毒样颗粒疫苗具有很高的持续疗效
7. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up [O] . Villa, L L, Costa, R L R, Petta, C A, 2006

机译：通过5年的随访，预防性的四价人乳头瘤病毒6/11/16/18型L1病毒样颗粒疫苗具有很高的持续疗效

Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine

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