Kavunga-Membo Hugo, Watson-Jones Deborah, Kasonia Kambale, Edwards Tansy, Camacho Anton, Mambula Grace, Tetsa-Tata Darius, Choi Edward Man-Lik, Aboubacar Soumah, Brindle Hannah, Roberts Chrissy, Manno Daniela, Faguer Benjamin, Mossoko Zephyrin, Mukadi Pierre, Kakule Michel, Balingene Benith, Mapendo Esther Kaningu, Makarimi Rockyath, Toure Oumar, Campbell Paul, Mousset Mathilde, Nsaibirni Robert, Ama Ibrahim Seyni, Janvier Kikongo Kambale, Keshinro Babajide, Cissé Badara, Sahani Mateus Kambale, Johnson John, Connor Nicholas, Lees Shelley, Imbault Nathalie, Robinson Cynthia, Grais Rebecca F, Bausch Daniel G, Muyembe-Tamfum Jean Jacques
Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo.
Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK.
Vaccines (Basel). 2024 Jul 23;12(8):825. doi: 10.3390/vaccines12080825.
During the 2018-2020 Ebola virus disease (EVD) outbreak, residents in Goma, Democratic Republic of the Congo, were offered a two-dose prophylactic EVD vaccine. This was the first study to evaluate the safety of this vaccine in pregnant women. Adults, including pregnant women, and children aged ≥1 year old were offered the Ad26.ZEBOV (day 0; dose 1), MVA-BN-Filo (day 56; dose 2) EVD vaccine through an open-label clinical trial. In total, 20,408 participants, including 6635 (32.5%) children, received dose 1. Fewer than 1% of non-pregnant participants experienced a serious adverse event (SAE) following dose 1; one SAE was possibly related to the Ad26.ZEBOV vaccine. Of the 1221 pregnant women, 371 (30.4%) experienced an SAE, with caesarean section being the most common event. No SAEs in pregnant women were considered related to vaccination. Of 1169 pregnancies with a known outcome, 55 (4.7%) ended in a miscarriage, and 30 (2.6%) in a stillbirth. Eleven (1.0%) live births ended in early neonatal death, and five (0.4%) had a congenital abnormality. Overall, 188/891 (21.1%) were preterm births and 79/1032 (7.6%) had low birth weight. The uptake of the two-dose regimen was high: 15,328/20,408 (75.1%). The vaccine regimen was well-tolerated among the study participants, including pregnant women, although further data, ideally from controlled trials, are needed in this crucial group.
在2018 - 2020年埃博拉病毒病（EVD）疫情期间，刚果民主共和国戈马的居民接种了两剂预防性EVD疫苗。这是评估该疫苗在孕妇中安全性的第一项研究。通过一项开放标签临床试验，为包括孕妇在内的成年人以及1岁及以上儿童提供了Ad26.ZEBOV（第0天；第1剂）、MVA - BN - Filo（第56天；第2剂）EVD疫苗。总共有20408名参与者，其中包括6635名（32.5%）儿童，接种了第1剂。不到1%的非孕妇参与者在接种第1剂后出现严重不良事件（SAE）；1例SAE可能与Ad26.ZEBOV疫苗有关。在1221名孕妇中，371名（30.4%）出现了SAE，剖宫产是最常见的事件。孕妇中没有SAE被认为与疫苗接种有关。在1169例已知结局的妊娠中，55例（4.7%）以流产告终，30例（2.6%）以死产告终。11例（1.0%）活产以早期新生儿死亡告终，5例（0.4%）有先天性异常。总体而言，188/891例（21.1%）为早产，79/1032例（7.6%）出生体重低。两剂方案的接种率很高：15328/20408（75.1%）。该疫苗方案在包括孕妇在内的研究参与者中耐受性良好，不过在这个关键群体中，理想情况下还需要来自对照试验的进一步数据。
