Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.

In this study, healthy women in Rwanda aged ≥18 years were randomized to two-dose Ebola vaccination (Ad26.ZEBOV, MVA-BN-Filo) during pregnancy (group A) or postpartum (group B).

在这项研究中，卢旺达年龄≥18岁的健康女性被随机分为两组，一组在怀孕期间（A组）接种两剂埃博拉疫苗（Ad26.ZEBOV, MVA-BN-Filo），另一组在产后（B组）。

Unvaccinated pregnant group B women served as control.

未接种疫苗的孕妇B组作为对照组。

This was a parallel, randomized, controlled, open-label, single-center trial to evaluate the safety (primary endpoint-outcomes of interest and serious adverse events (SAEs)) and immunogenicity (secondary endpoint) of the two-dose Ebola vaccination.

这是一项平行、随机、对照、开放标签、单中心试验，旨在评估两剂埃博拉疫苗的安全性（主要终点-感兴趣的结果和严重不良事件（SAEs））和免疫原性（次要终点）。

Among 3,484 women screened, 2,013 were randomized, and 2,012 women and 1,945 infants born alive were descriptively analyzed.

在3,484名接受筛查的女性中，有2,013名被随机分配，对2,012名女性和1,945名存活的婴儿进行了描述性分析。

Adverse outcomes of interest occurred in women (5.2% in group A and 7.3% in group B) and infants (26.0% in group A and 25.6% in group B).

感兴趣不良结局的发生率在女性中为A组5.2%，B组7.3%，在婴儿中为A组26.0%，B组25.6%。

The most common maternal outcome of interest was pathways to preterm birth (3.2% in group A and 3.4% in group B), and the most common infant outcome of interest was small for gestational age (14.3% in group A and 11.8% in group B).

最常关注的母婴结局是早产路径（A组为3.2%，B组为3.4%），最常关注的婴儿结局是小于胎龄儿（A组为14.3%，B组为11.8%）。

Maternal/fetal and neonatal/infant SAE frequencies were comparable between groups (9.8% in group A, 9.0% in group B and 21.9% in group A, 15.9% in group B, respectively).

两组之间的母胎和新生儿/婴儿严重不良事件(SAE)频率相当（A组为9.8%，B组为9.0%和A组为21.9%，B组为15.9%，分别计算）。

Anti-Ebola virus glycoprotein-specific binding antibody response (secondary endpoint) was sustained in ≥90% of women at 1 year postdose 1.

抗埃博拉病毒糖蛋白特异性结合抗体反应（次要终点）在首次剂量后1年时，在≥90%的女性中持续存在。

In group A, binding antibodies were detected in cord blood (99%) and infant serum (95%) samples 14 weeks postbirth.

在A组中，14周后在脐带血（99%）和婴儿血清（95%）样本中检测到结合抗体。

The trial met all primary and secondary objectives.

该试验达成了所有主要和次要目标。

Ad26.ZEBOV, MVA-BN-Filo did not raise concerns regarding adverse maternal/fetal or neonatal/infant outcomes, had no unexpected safety issues, and induced binding antibody responses in women and offspring through passive transfer.

Ad26.ZEBOV, MVA-BN-Filo在不良母婴或新生儿/婴儿结果方面未引起担忧，没有出现意外的安全问题，并且通过被动转移在女性及其后代中诱导了结合抗体反应。

ClinicalTrials.gov registration: NCT04556526 .

临床试验注册：NCT04556526。