Rotarix™ (RIX4414):: an oral human rotavirus vaccine
Rotarix™ (RIX4414):: an oral human rotavirus vaccine
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DOI：
10.1586/14760584.6.1.11
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发表时间：
2007-02-01
影响因子：
6.2
通讯作者：
O'Ryan, Miguel
中科院分区：
文献类型：
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作者：
O'Ryan, Miguel
轮状病毒是全球3岁以下儿童严重胃肠炎的最常见原因。新的轮状病毒候选疫苗被要求对最常见的轮状病毒血清型提供早期保护，并具有良好的耐受性，且与肠套叠无关。RIX4414是一种人类减毒G1(P8)口服轮状病毒疫苗，在大约6-24周龄时分两次接种。第一剂可以从6周大开始服用。根据生产商的说法，两次接种之间应至少有4周的间隔，接种疗程最好在16周之前进行，并必须在24周前完成。在一个涉及70,000多名儿童的全球开发项目中，有6个阶段的I-III现场试验，这种疫苗被证明是非反应性的，耐受性良好，与肠套叠无关。该疫苗对由G1和非G1血清型引起的中到重度胃肠炎提供了超过85%-96%的保护，分别在拉丁美洲和欧洲的临床试验环境中证明了这一点；在拉丁美洲和欧洲环境中，与胃肠炎相关的住院率分别减少了40%以上和75%。
Rotavirus is the most common cause of severe gastroenteritis in children younger than 3 years of age worldwide. New rotavirus vaccine candidates were required to confer early protection against the most common rotavirus serotypes and to be well tolerated and not associated with intussusception. RIX4414 is a human-attenuated G1 (P8) oral rotavirus vaccine administered in two doses at approximately 6-24 weeks of age. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses and the vaccination course should preferably be given before 16 weeks of age and must be completed, according to the manufacturer, by the age of 24 weeks. In a worldwide development program involving more than 70,000 children in six Phase I-III field trials, this vaccine proved to be nonreactogenic, well tolerated and not associated with intussusception. The vaccine provides over 85-96% protection against moderate-to-severe gastroenteritis caused by G1 and non-G1 serotypes, as demonstrated in Latin American and European clinical trial settings, respectively; and reduces gastroenteritis-related hospitalizations by more than 40% in Latin America and by 75% in European settings.