University of Tampere, Vaccine Research Centre, Tampere, Finland.
Clin Microbiol Infect. 2012 Oct;18 Suppl 5:57-63. doi: 10.1111/j.1469-0691.2012.03981.x. Epub 2012 Aug 6.
Live attenuated oral rotavirus vaccines were tested for proof-of-concept in the early 1980s, the first vaccine (RotaShield, Wyeth) was introduced in 1998 but was subsequently withdrawn because of association with intussusception, and the two currently licensed vaccine (Rotarix, GlaxoSmithKline, and RotaTeq, Merck) were introduced in 2006. Before licensure both vaccines were extensively tested for safety (for intussusception) and efficacy in trials comprising in over 60,000 infants each. Rotarix is a single-strain human rotavirus vaccine (RV1) and RotaTeq is a combination of five bovine-human reassortant rotaviruses (RV5). Although the composition of the two vaccines is different, their field effectiveness and, largely, mechanism of action are similar. Both prevent effectively severe rotavirus gastroenteritis (RVGE) but are less efficacious against mild RVGE or rotavirus infection. Field effectiveness of these vaccines in Europe and the USA against severe RVGE has been above 90% and in Latin America around 80%. Trials in Africa have yielded efficacy rates between 50 and 80%. Rotavirus vaccination has been introduced into the national immunization programmes of about 20 countries in Latin America, with Brazil and Mexico as leading countries, as well as in the USA, Australia and South Africa. Introduction into other African countries will start in 2012. In Europe, Belgium, Luxembourg, Austria and Finland and five federal states of Germany have introduced universal rotavirus vaccination. The reasons for the slow progress in Europe include low mortality from RVGE, unfavourable cost-benefit calculations in some countries, and concerns that still exist over intussusception.
口服减毒活轮状病毒疫苗在 20 世纪 80 年代早期进行了概念验证试验,第一种疫苗(RotaShield,惠氏)于 1998 年推出,但由于与肠套叠有关而被撤回,目前两种获得许可的疫苗(Rotarix,葛兰素史克和 RotaTeq,默克)于 2006 年推出。在获得许可之前,这两种疫苗都经过了广泛的安全性(肠套叠)和功效测试,每个试验都包含超过 60000 名婴儿。Rotarix 是一种单株人轮状病毒疫苗(RV1),而 RotaTeq 是由五种牛-人重组轮状病毒(RV5)组成的。虽然两种疫苗的成分不同,但它们的现场效果和作用机制基本相似。两者都能有效地预防严重轮状病毒胃肠炎(RVGE),但对轻度 RVGE 或轮状病毒感染的效果较差。这些疫苗在欧洲和美国的现场效果对严重 RVGE 的有效性超过 90%,在拉丁美洲约为 80%。在非洲的试验得出的疗效率在 50%至 80%之间。轮状病毒疫苗已被引入拉丁美洲约 20 个国家的国家免疫计划,巴西和墨西哥是主要国家,以及美国、澳大利亚和南非。其他非洲国家也将从 2012 年开始引入。在欧洲,比利时、卢森堡、奥地利和芬兰以及德国的五个联邦州已普遍接种轮状病毒疫苗。欧洲进展缓慢的原因包括 RVGE 死亡率低、一些国家的成本效益计算不利,以及对肠套叠的担忧仍然存在。