Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants
Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants
复制标题
Nirsevimab单次给药预防早产儿RSV
DOI：
10.1056/nejmoa1913556
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发表时间：
2020-07-30
影响因子：
158.5
通讯作者：
DeVincenzo, John P.
中科院分区：
文献类型：
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作者：
Griffin, M. Pamela;Yuan, Yuan;DeVincenzo, John P.
研究背景呼吸道合胞病毒（RSV）是婴幼儿下呼吸道感染的最常见病原体，因此需要在健康婴幼儿中预防RSV。Nirsevimab是一种单克隆抗体，具有延长的半衰期，正在开发，以保护整个RSV季节的婴儿与一个单一的肌内dose.MethodsIn这一试验进行了在北方和南半球，我们评估Nirsevimab的预防RSV相关的下呼吸道感染的健康婴儿早产（29周0天至34周6天的妊娠）。我们以2：1的比例随机分配婴儿接受Nirsevimab，单次肌肉注射50 mg，或在RSV季节开始时接受安慰剂。主要终点是给药后150天内出现的RSV相关下呼吸道感染。次要疗效终点为RSV相关下呼吸道感染住院治疗至给药后150 days。ResultsFrom November 2016 through November 2017，共有1453名婴儿在RSV季节开始时被随机分配接受nirsevimab（969名婴儿）或安慰剂（484名婴儿）。Nirsevimab预防治疗组的RSV相关下呼吸道感染发生率比安慰剂组低70.1%（95%置信区间[CI]，52.3 - 81.2）（2.6% [25例婴儿] vs. 9.5% [46例婴儿]; P
BackgroundRespiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose.MethodsIn this trial conducted in both northern and southern hemispheres, we evaluated nirsevimab for the prevention of RSV-associated lower respiratory tract infection in healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation). We randomly assigned the infants in a 2:1 ratio to receive nirsevimab, at a dose of 50 mg in a single intramuscular injection, or placebo at the start of an RSV season. The primary end point was medically attended RSV-associated lower respiratory tract infection through 150 days after administration of the dose. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after administration of the dose.ResultsFrom November 2016 through November 2017, a total of 1453 infants were randomly assigned to receive nirsevimab (969 infants) or placebo (484 infants) at the start of the RSV season. The incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower (95% confidence interval [CI], 52.3 to 81.2) with nirsevimab prophylaxis than with placebo (2.6% [25 infants] vs. 9.5% [46 infants]; P