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机译:研究新闻

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Merck' s V710 vaccine, developed to prevent infection with Staphylococcus aureus after heart surgery, failed to deliver. A trial done across 26 countries with more than 7000 participants was stopped early after a second preplanned interim analysis suggested the vaccine was ineffective and harmful. Despite a good antibody response to the vaccine, it was no more effective than placebo in preventing the primary outcome-S aureus bacteraemia or deep sternal wound infection (including mediastinitis), or both, up to postoperative day 90. This outcome was seen in 22 of 3528 patients randomised to the vaccine (2.6/100 person years) versus 27 of 3517 given placebo (3.2/100 person years); relative risk 0.81, 95% CI 0.44 to 1.48. No effect was seen on secondary outcomes either, which included all S aureus surgical sites and invasive infections to day 90. Adverse events were more common with the vaccine (30.8% v 21.8% with placebo), as were serious adverse events (1.7% v i.3%); 31 multiorgan failure events were seen with the vaccine versus 17 with placebo (0.9 v 0.5 per 100 person years; P=0.04). All cause mortality was similar in the two groups (5.7% v 5.0%), but people who developed staphy-lococcal infections after receiving the vaccine were more likely to die than those who received placebo (15/73 v4/96; difference 18.8/100 person years).
机译:默克的V710疫苗,防止开发后感染金黄色葡萄球菌的心手术,未能实现。26个国家拥有超过7000名参与者停止后早期一个预先计划的过渡分析表明,疫苗是无效的和有害的。疫苗,它没有更有效安慰剂预防主outcome-S球菌菌血症或深部胸骨伤口感染(包括纵隔炎),或者两者兼有,术后一天90。22岁的3528名患者随机疫苗人(2.6/100年)和3517年的27日安慰剂(3.2/100人年);0.81, 95%可信区间0.44到1.48。二次结果,其中包括所有的S球菌外科网站和侵入性感染一天90。疫苗与安慰剂(30.8% vs 21.8%)严重不良事件(1.7% v i.3%);被认为与multiorgan失败事件疫苗和17与安慰剂(每100人有0.5 0.9 v人年;两组相似(5.7% vs 5.0%),但是人发达staphy-lococcal感染在接受疫苗之后更有可能死比接受安慰剂(15/73 v4/96;区别18.8/100人年)。

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