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Molecular characterisation of rotavirus strains detected during a clinical trial of the human neonatal rotavirus vaccine (RV3-BB) in Indonesia

机译:在印度尼西亚人体新生儿Rotavirus疫苗(RV3-BB)的临床试验期间检测到旋流孔菌株的分子表征

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BackgroundThe RV3-BB human neonatal rotavirus vaccine aims to provide protection from severe rotavirus disease from birth. The aim of the current study was to characterise the rotavirus strains causing gastroenteritis during the Indonesian Phase IIb efficacy trial.MethodsA randomized, double-blind placebo-controlled trial involving 1649 participants was conducted from January 2013 to July 2016 in Central Java and Yogyakarta, Indonesia. Participants received three doses of oral RV3-BB vaccine with the first dose given at 0–5?days after birth (neonatal schedule), or the first dose given at?~8?weeks after birth (infant schedule), or placebo (placebo schedule). Stool samples from episodes of gastroenteritis were tested for rotavirus using EIA testing, positive samples were genotyped by RT-PCR. Full genome sequencing was performed on two representative rotavirus strains.ResultsThere were 1110 episodes of acute gastroenteritis of any severity, 105 episodes were confirmed as rotavirus gastroenteritis by EIA testing. The most common genotype identified was G3P[8] (90/105), the majority (52/56) of severe (Vesikari score?≥11) rotavirus gastroenteritis episodes were due to the G3P[8] strain. Full genome analysis of two representative G3P[8] samples demonstrated the strain was an inter-genogroup reassortant, containing an equine-like G3 VP7, P[8] VP4 and a genogroup 2 backbone I2-R2-C2-M2-A2-N2-T2-E2-H2. The complete genome of the Indonesian equine-like G3P[8] strain demonstrated highest genetic identity to G3P[8] strains circulating in Hungary and Spain.ConclusionsThe dominant circulating strain during the Indonesian Phase IIb efficacy trial of the RV3-BB vaccine was an equine-like G3P[8] strain. The equine-like G3P[8] strain is an emerging cause of severe gastroenteritis in Indonesia and in other regions.
机译:背景技术RV3-BB人体新生儿RotaVirus疫苗旨在提供从出生的严重轮状病毒疾病的保护。目前的研究目的是在印度尼西亚IIB疗效试验期间表征腐败病毒菌株。涉及1649年参与者的一项涉及1649年参与者的双盲安慰剂对照试验在2016年至2016年7月在印度尼西亚中央爪哇省和日惹。参与者接受了三剂量的口腔RV3-BB疫苗,其中第一剂在0-5?出生后的第一次(新生儿表),或在出生后的第一次给药(婴儿时间表)或安慰剂(安慰剂)日程)。使用EIA测试测试来自胃肠炎肠炎剧集的粪便样本,通过RT-PCR进行阳性样品进行阳性样品。在两个代表性的轮状病毒菌菌株中进行全基因组测序。评估是1110个急性胃肠炎的任何严重性的急性胃肠炎,通过EIA测试证实了105个发作作为轮状病毒胃肠炎。鉴定的最常见的基因型是G3P [8](90/105),大多数(52/56)严重(Vesikari得分呢?≥11)轮状病毒胃肠炎发作是由于G3P [8]菌株。两种代表性G3P [8]样品的全基因组分析证明了菌株是基于基因组的重新分子,含有马克式G3 VP7,P [8] VP4和GenoGroup 2骨架I2-R2-C2-M2-A2-N2 -T2-E2-H2。印度尼西亚徽章G3P [8]菌株的完整基因组在匈牙利和西班牙循环的G3P [8]菌株中表现出最高的遗传标识。在印度尼西亚IIB疫苗的印度尼西亚IIB疗效试验期间结论显性循环应变是马 - 状G3P [8]菌株。标准的G3P [8]菌株是印度尼西亚和其他地区严重胃肠炎的新兴原因。

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