Infectious Diseases and Vaccines - Clinical Research Department, Merck Research Laboratories, North Wales, PA, USA.
Vaccine. 2009 Dec 30;27 Suppl 6:G72-81. doi: 10.1016/j.vaccine.2009.09.107.
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.
轮状病毒疫苗的初始方法基于经典的“詹纳式”方法，利用猿猴和牛轮状病毒株，对人类轮状病毒株提供交叉保护，但由于其种特异性趋向性，不会在婴儿和幼儿中引起疾病。这些疫苗的功效在不同的研究中并不一致。因此，开发了含有动物轮状病毒骨架和人类轮状病毒表面 G 和/或 P 蛋白的人-动物重组疫苗，其功效比非重组轮状病毒株更为一致。五价轮状病毒疫苗 RotaTeq 含有 5 种人-牛重组轮状病毒，由牛（WC3）骨架与代表全球最常见 G（G1、G2、G3、G4）或 P（P1A[8]）型的人轮状病毒表面蛋白组成。本综述重点介绍了五价轮状病毒疫苗 RotaTeq 的开发。一项大规模 III 期临床研究结果表明，RotaTeq 接种三剂具有免疫原性、疗效和良好的耐受性，没有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%）的轮状病毒胃肠炎均有效。在接种疫苗后长达 2 年的时间内，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%。RotaTeq 最近在常规使用中显示出在美国降低住院和急诊就诊的有效性高达 100%，并降低 96%的医生就诊。在美国 8 个不同地点的额外研究表明，在常规使用的前 2-2.5 年内，轮状病毒相关住院和/或急诊就诊的减少率为 85-95%。
