Rotavirus Vaccine Program, PATH, 2201 Westlake Ave, Seattle, WA 98121, USA.
BMC Infect Dis. 2012 Sep 13;12:213. doi: 10.1186/1471-2334-12-213.
Rotaviruses are the most important cause of severe acute gastroenteritis worldwide in children <5 years of age. The human, G1P[8] rotavirus vaccine Rotarix™ significantly reduced severe rotavirus gastroenteritis episodes in a Phase III clinical trial conducted in infants in South Africa and Malawi. This paper examines rotavirus vaccine efficacy in preventing severe rotavirus gastroenteritis, during infancy, caused by the various G and P rotavirus types encountered during the first rotavirus-season.
Healthy infants aged 5-10 weeks were enrolled and randomized into three groups to receive either two (10 and 14 weeks) or three doses of Rotarix™ (together forming the pooled Rotarix™ group) or three doses of placebo at a 6,10,14-week schedule. Weekly home visits were conducted to identify gastroenteritis episodes. Rotaviruses were detected by ELISA and genotyped by RT-PCR and nucleotide sequencing. The percentage of infants with severe rotavirus gastroenteritis caused by the circulating G and P types from 2 weeks post-last dose until one year of age and the corresponding vaccine efficacy was calculated with 95% CI.
Overall, 4939 infants were vaccinated and 4417 (pooled Rotarix™ = 2974; placebo = 1443) were included in the per protocol efficacy cohort. G1 wild-type was detected in 23 (1.6%) severe rotavirus gastroenteritis episodes from the placebo group. This was followed in order of detection by G12 (15 [1%] in placebo) and G8 types (15 [1%] in placebo). Vaccine efficacy against G1 wild-type, G12 and G8 types were 64.1% (95% CI: 29.9%; 82%), 51.5% (95% CI:-6.5%; 77.9%) and 64.4% (95% CI: 17.1%; 85.2%), respectively. Genotype P[8] was the predominant circulating P type and was detected in 38 (2.6%) severe rotavirus gastroenteritis cases in placebo group. The remaining circulating P types comprised of P[4] (20 [1.4%] in placebo) and P[6] (13 [0.9%] in placebo). Vaccine efficacy against P[8] was 59.1% (95% CI: 32.8%; 75.3%), P[4] was 70.9% (95% CI: 37.5%; 87.0%) and P[6] was 55.2% (95% CI: -6.5%; 81.3%)
Rotarix™ vaccine demonstrated efficacy against severe gastroenteritis caused by diverse circulating rotavirus types. These data add to a growing body of evidence supporting heterotypic protection provided by Rotarix™.
NCT00241644.
轮状病毒是全球 5 岁以下儿童严重急性胃肠炎的最重要原因。人类 G1P[8]轮状病毒疫苗 Rotarix™ 在南非和马拉维进行的一项针对婴儿的 III 期临床试验中显著降低了严重轮状病毒胃肠炎发作的频率。本文研究了 Rotarix™ 在预防轮状病毒季节中遇到的各种 G 和 P 型轮状病毒引起的婴儿严重轮状病毒胃肠炎方面的疫苗疗效。
健康的 5-10 周龄婴儿被招募并随机分为三组，分别接受两次（10 周和 14 周）或三次（总共形成 Pooled Rotarix™ 组）Rotarix™ 或三次安慰剂，接种时间为 6、10、14 周。每周进行家庭访视以识别胃肠炎发作。通过 ELISA 检测轮状病毒，并通过 RT-PCR 和核苷酸测序进行基因分型。从最后一次接种后 2 周到 1 岁期间，计算了循环 G 和 P 型引起的严重轮状病毒胃肠炎的婴儿百分比以及相应的疫苗疗效，并计算了 95%置信区间。
总体而言，4939 名婴儿接种了疫苗，4417 名（Pooled Rotarix™=2974；安慰剂=1443）婴儿被纳入方案疗效队列。在安慰剂组中，有 23 例（1.6%）严重轮状病毒胃肠炎病例检测到野生型 G1。其次是 G12（安慰剂中 15 例[1%]）和 G8 型（安慰剂中 15 例[1%]）。针对野生型 G1、G12 和 G8 型的疫苗效力分别为 64.1%（95%CI：29.9%；82%）、51.5%（95%CI：-6.5%；77.9%）和 64.4%（95%CI：17.1%；85.2%）。基因型 P[8]是主要循环 P 型，在安慰剂组中 38 例（2.6%）严重轮状病毒胃肠炎病例中检测到。其余循环 P 型包括 P[4]（安慰剂中 20 例[1.4%]）和 P[6]（安慰剂中 13 例[0.9%]）。针对 P[8]的疫苗效力为 59.1%（95%CI：32.8%；75.3%），针对 P[4]的疫苗效力为 70.9%（95%CI：37.5%；87.0%），针对 P[6]的疫苗效力为 55.2%（95%CI：-6.5%；81.3%）。
Rotarix™ 疫苗对多种循环轮状病毒引起的严重胃肠炎具有疗效。这些数据为 Rotarix™ 提供的异源保护提供了越来越多的证据支持。
NCT00241644。
