轮状病毒疫苗的开发：五价轮状病毒疫苗RotaTeq的临床安全性，免疫原性和功效。,Vaccine

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轮状病毒疫苗的开发：五价轮状病毒疫苗RotaTeq的临床安全性，免疫原性和功效。
Vaccine ( IF 4.5 ) Pub Date : 2009-12-17 , DOI: 10.1016/j.vaccine.2009.09.107
Max Ciarlet ₁ , Florian Schödel

Affiliation

轮状病毒疫苗的最初方法是基于经典的“ Jennerian”方法，并使用了猿猴和牛轮状病毒株，它们对人轮状病毒株具有交叉保护作用，但由于其物种特异性而不会引起婴幼儿患病。这些疫苗的功效在研究之间并不一致。因此，开发了包含具有人轮状病毒表面G和/或P蛋白的动物轮状病毒主链的人-动物重配体，与非重配体轮状病毒株相比，其表现出更一致的功效。五价轮状病毒疫苗RotaTeq包含5种人牛重组轮状病毒，由牛（WC3）骨架和代表最常见G（G1，G2，G3，G4）或P（P1A [8]）类型。目前的审查集中在五价轮状病毒疫苗RotaTeq的发展。一项大规模的III期临床研究结果表明，三剂RotaTeq具有免疫原性，有效度和良好的耐受性，且不会增加肠套叠的临床风险。使用经过验证的临床评分系统，RotaTeq对任何严重程度（74％）和严重疾病（98-100％）的轮状病毒肠胃炎均有效。疫苗接种后长达2年的轮状病毒相关住院和急诊就诊的减少在欧洲为95％，在美国为97％，在拉丁美洲/加勒比地区为90％。最近显示，RotaTeq在美国常规使用中可有效减少住院和急诊就诊，有效率高达100％，在减少内科医生就诊率方面可达到96％。

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Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq.

Initial approaches for rotavirus vaccines were based on the classical "Jennerian" approach and utilized simian and bovine rotavirus strains, which provided cross-protection against human rotavirus strains but did not cause illness in infants and young children because of their species-specific tropism. The demonstrated efficacy of these vaccines was not consistent across studies. Thus, human-animal reassortants containing an animal rotavirus backbone with human rotavirus surface G and/or P proteins were developed, which demonstrated more consistent efficacy than that observed with the non-reassortant rotavirus strains. The pentavalent rotavirus vaccine, RotaTeq, contains 5 human-bovine reassortant rotaviruses consisting of a bovine (WC3) backbone with human rotavirus surface proteins representative of the most common G (G1, G2, G3, G4) or P (P1A[8]) types worldwide. The present review focuses on the development of the pentavalent rotavirus vaccine RotaTeq. Results of a large-scale Phase III clinical study showed that three doses of RotaTeq were immunogenic, efficacious, and well tolerated with no increased clinical risk of intussusception. RotaTeq was efficacious against rotavirus gastroenteritis of any severity (74%) and severe disease (98-100%), using a validated clinical scoring system. Reductions in rotavirus-associated hospitalizations and emergency department (ED) visits, for up to 2 years post-vaccination, were 95% in Europe, 97% in the United States, and 90% in the Latin American/Caribbean regions. RotaTeq was recently shown to be up to 100% effective in routine use in the US in reducing hospitalizations and ED visits and 96% effective in reducing physician visits. Additional studies in 8 different locations in the US have shown 85-95% reduction in rotavirus-associated hospitalizations and/or ED visits in the first 2-2.5 years of routine use.

更新日期：2019-11-01

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