Vaccines (Jul 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
- 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
Affiliations
- Hugo Kavunga-Membo
- Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
- Deborah Watson-Jones
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Kambale Kasonia
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Tansy Edwards
- School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki 852-8131, Japan
- Anton Camacho
- Epicentre, 75019 Paris, France
- Grace Mambula
- Epicentre, 75019 Paris, France
- Darius Tetsa-Tata
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Edward Man-Lik Choi
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Soumah Aboubacar
- Epicentre, 75019 Paris, France
- Hannah Brindle
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Chrissy Roberts
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Daniela Manno
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Benjamin Faguer
- Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
- Zephyrin Mossoko
- Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
- Pierre Mukadi
- Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
- Michel Kakule
- Epicentre, 75019 Paris, France
- Benith Balingene
- Epicentre, 75019 Paris, France
- Esther Kaningu Mapendo
- Epicentre, 75019 Paris, France
- Rockyath Makarimi
- Epicentre, 75019 Paris, France
- Oumar Toure
- Epicentre, 75019 Paris, France
- Paul Campbell
- Epicentre, 75019 Paris, France
- Mathilde Mousset
- Epicentre, 75019 Paris, France
- Robert Nsaibirni
- Epicentre, 75019 Paris, France
- Ibrahim Seyni Ama
- Epicentre, 75019 Paris, France
- Kikongo Kambale Janvier
- Epicentre, 75019 Paris, France
- Babajide Keshinro
- Janssen Vaccines and Prevention, 2333 CN Leiden, The Netherlands
- Badara Cissé
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Mateus Kambale Sahani
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- John Johnson
- Médecins Sans Frontières, 75019 Paris, France
- Nicholas Connor
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Shelley Lees
- Faculty of Public Health & Policy, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK
- Nathalie Imbault
- Coalition for Epidemic Preparedness Innovations, 0277 Oslo, Norway
- Cynthia Robinson
- Janssen Vaccines and Prevention, 2333 CN Leiden, The Netherlands
- Rebecca F. Grais
- Epicentre, 75019 Paris, France
- Daniel G. Bausch
- Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK
- Jean Jacques Muyembe-Tamfum
- Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo
- DOI
- https://doi.org/10.3390/vaccines12080825
- Journal volume & issue
-
Vol. 12,
no. 8
p. 825
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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