ArticleVaccines2024
Delivery and Safety of a Two-Dose Preventive Ebola Virus Disease Vaccine in Pregnant and Non-Pregnant Participants during an Outbreak in the Democratic Republic of the Congo.
Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed.
- Trial
- Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy.Human vaccines & immunotherapeutics · 2025Trial
- Protecting pregnancy during pandemics: What recent outbreaks teach us.Human vaccines & immunotherapeutics · 2025Review
- Rumor as ethical vernacular: Ebola and the womb in eastern Congo.Medical anthropology quarterly · 2025Article
- When Combatting Ebola and other Outbreak-Prone Pathogens, Global Health is American's Health.The American journal of tropical medicine and hygiene · 2025Article
- Using an analogue-digital hybrid clinical data management platform during a two-dose preventive Ebola virus vaccine trial in Goma, the Democratic Republic of the Congo.PLOS global public health · 2025Article
- Article
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Authors and funding
36 authors.
Funding
Abstract
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.
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Registered trials
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