| Autor: |
Hugo Kavunga-Membo, Deborah Watson-Jones, Kambale Kasonia, Tansy Edwards, Anton Camacho, Grace Mambula, Darius Tetsa-Tata, Edward Man-Lik Choi, Soumah Aboubacar, Hannah Brindle, Chrissy Roberts, Daniela Manno, Benjamin Faguer, Zephyrin Mossoko, Pierre Mukadi, Michel Kakule, Benith Balingene, Esther Kaningu Mapendo, Rockyath Makarimi, Oumar Toure, Paul Campbell, Mathilde Mousset, Robert Nsaibirni, Ibrahim Seyni Ama, Kikongo Kambale Janvier, Babajide Keshinro, Badara Cissé, Mateus Kambale Sahani, John Johnson, Nicholas Connor, Shelley Lees, Nathalie Imbault, Cynthia Robinson, Rebecca F. Grais, Daniel G. Bausch, Jean Jacques Muyembe-Tamfum |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Vaccines, Vol 12, Iss 8, p 825 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2076-393X |
| DOI: |
10.3390/vaccines12080825 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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