本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2305478

摘要内容如下：

背景

在怀孕期间接种呼吸道合胞病毒（RSV）疫苗可以保护婴儿免受RSV疾病。需要基于候选RSV预融合F蛋白的母体疫苗（RSVPref3-MAT）的有效性和安全性数据。

方法

我们进行了一项涉及18至49岁孕妇的3期临床试验，以评估RSVPref3-MAT的疗效和安全性。这些妇女以2:1的比例随机分配，在妊娠24周0天和34周0天之间接受RSVPREF3-MAT或安慰剂。主要转归是从出生到6个月大的婴儿中经医学评估的任何或严重的RSV相关下呼吸器官疾病，以及从出生到12个月大的婴儿的安全性。在观察到疫苗组的早产风险高于安慰剂组后，提前停止登记和接种疫苗，并对早产的安全性信号进行探索性分析。

结果

分析对象包括5328名孕妇和5233名婴儿。约10000名孕妇及其婴儿的目标登记人数没有达到，因为登记工作提前停止。从出生到6个月，共随访了疫苗组的3426名婴儿和安慰剂组的1711名婴儿。分别有16名和24名婴儿患有任何经医学评估的RSV相关低呼吸器官疾病（疫苗效力，65.5%；95%可信区间，37.5至82.0），8例和14例分别有严重的医学评估为RSV相关的低呼吸器官疾病（疫苗效力，69.0%；95%可信区间为33.0~87.6）。疫苗组婴儿的早产率为6.8%（237/3494），安慰剂组为4.9%（86/1739）（相对危险度:1.37；95%置信区间[CI]，1.08至1.74；P=0.01）；新生儿死亡率分别为0.4%（13/3494）和0.2%（3/1739）（相对危险度2.16；95%可信区间为0.62~7.56；P=0.23），这种不平衡可能归因于疫苗组中早产的百分比更高。未观察到其他安全信号。

结论

在该试验中，出于安全考虑，招募工作被提前终止，试验结果表明，与安慰剂相比，使用候选母体RSV疫苗的婴儿患任何经医学评估的严重RSV相关低呼吸器官疾病的风险较低，但使用候选疫苗的早产风险较高。（由GlaxoSmithKline Biologicals资助；ClinicalTrials.gov编号，NCT04605159。）

英文原文如下：

Abstracts

BACKGROUND  Vaccination against respiratory syncytial virus (RSV) during pregnancy may protect infants from RSV disease. Efficacy and safety data on a candidate RSV prefusion F protein-based maternal vaccine (RSVPreF3-Mat) are needed.

METHODS  We conducted a phase 3 trial involving pregnant women 18 to 49 years of age to assess the efficacy and safety of RSVPreF3-Mat. The women were randomly assigned in a 2:1 ratio to receive RSVPreF3-Mat or placebo between 24 weeks 0 days and 34 weeks 0 days of gestation. The primary outcomes were any or severe medically assessed RSV-associated lower respiratory tract disease in infants from birth to 6 months of age and safety in infants from birth to 12 months of age. After the observation of a higher risk of preterm birth in the vaccine group than in the placebo group, enrollment and vaccination were stopped early, and exploratory analyses of the safety signal of preterm birth were performed.

RESULTS  The analyses included 5328 pregnant women and 5233 infants; the target enrollment of approximately 10,000 pregnant women and their infants was not reached because enrollment was stopped early. A total of 3426 infants in the vaccine group and 1711 infants in the placebo group were followed from birth to 6 months of age; 16 and 24 infants, respectively, had any medically assessed RSV-associated lower respiratory tract disease (vaccine efficacy, 65.5%; 95% credible interval, 37.5 to 82.0), and 8 and 14, respectively, had severe medically assessed RSV-associated lower respiratory tract disease (vaccine efficacy, 69.0%; 95% credible interval, 33.0 to 87.6). Preterm birth occurred in 6.8% of the infants (237 of 3494) in the vaccine group and in 4.9% of those (86 of 1739) in the placebo group (relative risk, 1.37; 95% confidence interval [CI], 1.08 to 1.74; P = 0.01); neonatal death occurred in 0.4% (13 of 3494) and 0.2% (3 of 1739), respectively (relative risk, 2.16; 95% CI, 0.62 to 7.56; P = 0.23), an imbalance probably attributable to the greater percentage of preterm births in the vaccine group. No other safety signal was observed.

CONCLUSIONS  The results of this trial, in which enrollment was stopped early because of safety concerns, suggest that the risks of any and severe medically assessed RSV-associated lower respiratory tract disease among infants were lower with the candidate maternal RSV vaccine than with placebo but that the risk of preterm birth was higher with the candidate vaccine. (Funded by GlaxoSmithKline Biologicals; ClinicalTrials.gov number, NCT04605159.).

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