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.
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;
+26 more...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;
(2024)
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.
Vaccines, 12 (8).
p. 825.
DOI: https://doi.org/10.3390/vaccines12080825
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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.
