From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).
N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.
Respiratory 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.
In 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.
From 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<0.001) and the incidence of hospitalization for RSV-associated lower respiratory tract infection was 78.4% lower (95% CI, 51.9 to 90.3) with nirsevimab than with placebo (0.8% [8 infants] vs. 4.1% [20 infants]; P<0.001). These differences were consistent throughout the 150-day period after the dose was administered and across geographic locations and RSV subtypes. Adverse events were similar in the two trial groups, with no notable hypersensitivity reactions.
A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants. (Funded by AstraZeneca and Sanofi Pasteur; ClinicalTrials.gov number, NCT02878330.).
呼吸道合胞病毒（RSV）是婴儿下呼吸道感染最常见的原因，需要预防健康婴儿感染 RSV。尼尔斯维拉单抗是一种具有延长半衰期的单克隆抗体，正在开发中，用于通过单次肌肉注射为整个 RSV 季节提供保护。
在南北半球进行的这项试验中，我们评估了尼尔斯维拉单抗预防早产（胎龄 29 周 0 天至 34 周 6 天）婴儿 RSV 相关下呼吸道感染的效果。我们将婴儿以 2:1 的比例随机分配，接受尼尔斯维拉单抗（单次肌肉注射 50mg）或安慰剂，在 RSV 季节开始时给药。主要终点是给药后 150 天内因 RSV 相关下呼吸道感染而接受治疗。次要疗效终点是给药后 150 天内因 RSV 相关下呼吸道感染住院。
2016 年 11 月至 2017 年 11 月，共有 1453 名婴儿在 RSV 季节开始时被随机分配接受尼尔斯维拉单抗（969 名婴儿）或安慰剂（484 名婴儿）。尼尔斯维拉单抗预防组 RSV 相关下呼吸道感染的发生率比安慰剂组低 70.1%（95%置信区间[CI]，52.3 至 81.2）（2.6%[25 名婴儿] vs. 9.5%[46 名婴儿]；P<0.001），因 RSV 相关下呼吸道感染住院的发生率低 78.4%（95%CI，51.9 至 90.3）（0.8%[8 名婴儿] vs. 4.1%[20 名婴儿]；P<0.001）。这些差异在给药后 150 天内持续存在，且在不同地理位置和 RSV 亚型中一致。两组试验中不良反应相似，无明显过敏反应。
在健康早产儿整个 RSV 季节中，单次注射尼尔斯维拉单抗比安慰剂可减少 RSV 相关下呼吸道感染和住院的次数。（由阿斯利康和赛诺菲巴斯德资助；ClinicalTrials.gov 编号，NCT02878330。）
