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

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 ye...

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Vydáno v:Vaccines Ročník 12; číslo 8; s. 825
Hlavní autoři: 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
Médium: Journal Article
Jazyk:angličtina
Vydáno: Switzerland MDPI AG 23.07.2024
MDPI
Témata:
Ad26.ZEBOV/MVA-BN-Filo
Babies
Birth weight
Births
Breastfeeding & lactation
Case reports
Cesarean section
Children
Clinical trials
Consent
DRC
Ebola
Ebola virus
Ebolavirus
Fatalities
Hypothesis testing
Immunization
Low birth weight
Medicine
Menstruation
Neonates
outbreak
Outbreaks
Pregnancy
Premature birth
Public health
R
safety
vaccine
Vaccines
Viral diseases
Womens health
Congo-Democratic Republic of Congo
United States > US
vaccine
pregnant women
DRC
safety
outbreak
Ad26.ZEBOV/MVA-BN-Filo
general population
Ebola
ISSN:2076-393X, 2076-393X
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Shrnutí: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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These authors contributed equally to this work.
ISSN:2076-393X
2076-393X
DOI:10.3390/vaccines12080825