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印度源自新生儿毒株的轮状病毒候选疫苗的研发。

Development of candidate rotavirus vaccines derived from neonatal strains in India.

作者信息

Glass Roger I, Bhan Maharaj K, Ray Pratima, Bahl Rajiv, Parashar Umesh D, Greenberg Harry, Rao C Durga, Bhandari Nita, Maldonado Yvonne, Ward Richard L, Bernstein David I, Gentsch Jon R

机构信息

Respiratory and Enteric Viruses Branch, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

出版信息

J Infect Dis. 2005 Sep 1;192 Suppl 1:S30-5. doi: 10.1086/431498.

DOI:10.1086/431498
PMID:16088802
Abstract

The need for a rotavirus vaccine in India is based on the enormous burden associated with the >100,000 deaths due to rotavirus diarrhea that occur annually among Indian children. Two rotavirus strains identified during nosocomial outbreaks of rotavirus infection in New Delhi and Bangalore, India, more than a decade ago are being developed as live oral vaccines. Infected newborns had no symptoms, shed virus for up to 2 weeks after infection, mounted a robust immune response, and demonstrated protection against severe rotavirus diarrhea after reinfection. The 2 strains are naturally occurring bovine-human reassortants. The New Delhi strain, 116E, is characterized as having a P[11],G9 genotype, and the Bangalore strain, I321, is characterized as having a P[11],G10 genotype. The strains have been prepared as pilot lots for clinical trials to be conducted in New Delhi. This unique project, which is developing a new rotavirus vaccine in India with the use of Indian strains, an Indian manufacturer, and an Indian clinical development program, aims to expedite introduction of rotavirus vaccines in India.

摘要

在印度,轮状病毒疫苗的需求源于每年有超过10万名印度儿童因轮状病毒腹泻死亡所带来的巨大负担。十多年前在印度新德里和班加罗尔的医院内轮状病毒感染暴发期间鉴定出的两种轮状病毒株,正被开发为口服活疫苗。受感染的新生儿没有症状,感染后长达2周都能排出病毒,产生了强烈的免疫反应,并且再次感染后显示出对严重轮状病毒腹泻的保护作用。这两种毒株是天然存在的牛-人重配体。新德里毒株116E的特征是具有P[11]、G9基因型,而班加罗尔毒株I321的特征是具有P[11]、G10基因型。这些毒株已制成试验批次,用于在新德里开展临床试验。这个独特的项目利用印度毒株、一家印度制造商和一个印度临床开发计划在印度开发一种新型轮状病毒疫苗,旨在加快轮状病毒疫苗在印度的引进。

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