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 |
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23.07.2024
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| 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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| AbstractList | 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. 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.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. |
| Author | Edward Man-Lik Choi Hugo Kavunga-Membo Mateus Kambale Sahani Paul Campbell Benjamin Faguer Anton Camacho Hannah Brindle Rockyath Makarimi Nathalie Imbault Deborah Watson-Jones Soumah Aboubacar Mathilde Mousset Benith Balingene Cynthia Robinson John Johnson Zephyrin Mossoko Daniela Manno Jean Jacques Muyembe-Tamfum Grace Mambula Kambale Kasonia Tansy Edwards Michel Kakule Darius Tetsa-Tata Daniel G. Bausch Oumar Toure Ibrahim Seyni Ama Shelley Lees Nicholas Connor Rebecca F. Grais Pierre Mukadi Babajide Keshinro Robert Nsaibirni Chrissy Roberts Kikongo Kambale Janvier Esther Kaningu Mapendo Badara Cissé |
| AuthorAffiliation | 5 Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK; benjamin.faguer@icloud.com 2 Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK; kambale.kasonia@lshtm.ac.uk (K.K.); darius.tetsatata@lshtm.ac.uk (D.T.-T.); edward.choi@lshtm.ac.uk (E.M.-L.C.); hannah.brindle@lshtm.ac.uk (H.B.); chrissy.roberts@lshtm.ac.uk (C.R.); daniela.manno@lshtm.ac.uk (D.M.); badara.cisse@iressef.org (B.C.); mateus-kambale.sahani@lshtm.ac.uk (M.K.S.); nicholas.connor@lshtm.ac.uk (N.C.); daniel.bausch@finddx.org (D.G.B.) 3 Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza P.O. Box 1462, Tanzania 1 Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo; hugokavunga@gmail.com (H.K.-M.); zmossoko@yahoo.fr (Z.M.); kepha4@hotmail.com (P.M.); jjmuyembet@gmail.com (J.J.M.-T.) 4 School of Tropical Medicine and Global Health, Nagasa |
| AuthorAffiliation_xml | – name: 8 Médecins Sans Frontières, 75019 Paris, France; john.johnson@paris.msf.org – name: 6 Epicentre, 75019 Paris, France; anton.camacho@epicentre.msf.org (A.C.); grace.mambula@epicentre.msf.org (G.M.); soumahaboubacar82@yahoo.fr (S.A.); michelkahumba@yahoo.fr (M.K.); benqbali@gmail.com (B.B.); kaninguesthermap@gmail.com (E.K.M.); costoreau@gmail.com (R.M.); oumar.toure@epicentre.msf.org (O.T.); paul.campbell@epicentre.msf.org (P.C.); mathilde.mousset@epicentre.msf.org (M.M.); robert.nsaibirni@epicentre.msf.org (R.N.); wandeybaisa@gmail.com (I.S.A.); kikongokambale@gmail.com (K.K.J.); rebecca.grais@pasteur.fr (R.F.G.) – name: 2 Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London WC1E 7HT, UK; kambale.kasonia@lshtm.ac.uk (K.K.); darius.tetsatata@lshtm.ac.uk (D.T.-T.); edward.choi@lshtm.ac.uk (E.M.-L.C.); hannah.brindle@lshtm.ac.uk (H.B.); chrissy.roberts@lshtm.ac.uk (C.R.); daniela.manno@lshtm.ac.uk (D.M.); badara.cisse@iressef.org (B.C.); mateus-kambale.sahani@lshtm.ac.uk (M.K.S.); nicholas.connor@lshtm.ac.uk (N.C.); daniel.bausch@finddx.org (D.G.B.) – name: 7 Janssen Vaccines and Prevention, 2333 CN Leiden, The Netherlands; bkeshinr@its.jnj.com (B.K.); crobin29@its.jnj.com (C.R.) – name: 1 Institut National de Recherche Biomédicale, Kinshasa P.O. Box 1192, Democratic Republic of the Congo; hugokavunga@gmail.com (H.K.-M.); zmossoko@yahoo.fr (Z.M.); kepha4@hotmail.com (P.M.); jjmuyembet@gmail.com (J.J.M.-T.) – name: 5 Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK; benjamin.faguer@icloud.com – name: 4 School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki 852-8131, Japan; tansy.edwards@lshtm.ac.uk – name: 9 Faculty of Public Health & Policy, London School of Hygiene & Tropical Medicine, London WC1E 7HT, UK; shelley.lees@lshtm.ac.uk – name: 11 Foundation for Innovative New Diagnostics (FIND), Campus Biotech Chemin des Mines 9, 1202 Geneva, Switzerland – name: 10 Coalition for Epidemic Preparedness Innovations, 0277 Oslo, Norway; nathalie.imbault@cepi.net – name: 3 Mwanza Intervention Trials Unit, National Institute for Medical Research, Mwanza P.O. Box 1462, Tanzania |
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| Copyright | 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2024 by the authors. 2024 |
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