尼赛珠单抗预防健康晚期早产儿和足月婴儿 RSV 感染。
Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.
机构信息
From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quirónsalud Málaga Hospital, Malaga, Spain (M.B.C.); University Multiprofile Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria (M.B.); the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.), and the Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town (H.J.Z.) - all in South Africa; Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago (W.J.M.); AstraZeneca, Gothenburg, Sweden (U.W.H.); and AstraZeneca, Durham, NC (V.S.M.).
出版信息
N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
BACKGROUND
Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection and hospitalization in infants. Nirsevimab is a monoclonal antibody to the RSV fusion protein that has an extended half-life. The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain.
METHODS
We randomly assigned, in a 2:1 ratio, infants who had been born at a gestational age of at least 35 weeks to receive a single intramuscular injection of nirsevimab or placebo before the start of an RSV season. The primary efficacy end point was medically attended RSV-associated lower respiratory tract infection through 150 days after the injection. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after the injection.
RESULTS
A total of 1490 infants underwent randomization: 994 were assigned to the nirsevimab group and 496 to the placebo group. Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group; these findings correspond to an efficacy of 74.5% (95% confidence interval [CI], 49.6 to 87.1; P<0.001) for nirsevimab. Hospitalization for RSV-associated lower respiratory tract infection occurred in 6 infants (0.6%) in the nirsevimab group and in 8 infants (1.6%) in the placebo group (efficacy, 62.1%; 95% CI, -8.6 to 86.8; P = 0.07). Among infants with data available to day 361, antidrug antibodies after baseline were detected in 58 of 951 (6.1%) in the nirsevimab group and in 5 of 473 (1.1%) in the placebo group. Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo.
CONCLUSIONS
A single injection of nirsevimab administered before the RSV season protected healthy late-preterm and term infants from medically attended RSV-associated lower respiratory tract infection. (Funded by MedImmune/AstraZeneca and Sanofi; MELODY ClinicalTrials.gov number, NCT03979313.).
背景
呼吸道合胞病毒（RSV）是导致婴儿下呼吸道感染和住院的主要原因。尼司维拉单抗是一种针对 RSV 融合蛋白的单克隆抗体，具有延长的半衰期。尼司维拉单抗在健康晚期早产儿和足月婴儿中的疗效和安全性尚不确定。
方法
我们以 2:1 的比例随机分配出生胎龄至少为 35 周的婴儿，在 RSV 季节开始前接受单次肌内注射尼司维拉单抗或安慰剂。主要疗效终点是注射后 150 天内需要医疗干预的 RSV 相关下呼吸道感染。次要疗效终点是注射后 150 天内因 RSV 相关下呼吸道感染而住院。
结果
共有 1490 名婴儿接受了随机分组：994 名婴儿分入尼司维拉单抗组，496 名婴儿分入安慰剂组。尼司维拉单抗组有 12 名（1.2%）婴儿发生需要医疗干预的 RSV 相关下呼吸道感染，安慰剂组有 25 名（5.0%）婴儿发生该事件；尼司维拉单抗的疗效为 74.5%（95%置信区间[CI]，49.6 至 87.1；P<0.001）。尼司维拉单抗组有 6 名（0.6%）婴儿因 RSV 相关下呼吸道感染而住院，安慰剂组有 8 名（1.6%）婴儿因 RSV 相关下呼吸道感染而住院（疗效为 62.1%；95%CI，-8.6 至 86.8；P = 0.07）。在接受至第 361 天数据的婴儿中，尼司维拉单抗组有 951 名婴儿中的 58 名（6.1%）和安慰剂组有 473 名婴儿中的 5 名（1.1%）在基线后检测到抗药物抗体。尼司维拉单抗组有 987 名婴儿中的 67 名（6.8%）和安慰剂组有 491 名婴儿中的 36 名（7.3%）报告了严重不良事件。
结论
在 RSV 季节前单次注射尼司维拉单抗可预防健康晚期早产儿和足月婴儿发生需要医疗干预的 RSV 相关下呼吸道感染。（由 MedImmune/AstraZeneca 和赛诺菲资助；MELODY ClinicalTrials.gov 编号，NCT03979313。）
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