{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T11:21:59Z","timestamp":1790421719171,"version":"4.1.0"},"reference-count":28,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2022,3,7]],"date-time":"2022-03-07T00:00:00Z","timestamp":1646611200000},"content-version":"unspecified","delay-in-days":6,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010661","name":"Horizon 2020 Framework Programme","doi-asserted-by":"publisher","award":["857935"],"award-info":[{"award-number":["857935"]}],"id":[{"id":"10.13039\/100010661","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016302","name":"Coalition for Epidemic Preparedness Innovations","doi-asserted-by":"publisher","award":["FELS1903"],"award-info":[{"award-number":["FELS1903"]}],"id":[{"id":"10.13039\/100016302","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010269","name":"Wellcome","doi-asserted-by":"publisher","award":["220506\/Z\/20\/Z"],"award-info":[{"award-number":["220506\/Z\/20\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000952","name":"Paul G. Allen Family Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000952","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000278","name":"Department for International Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000278","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,12,17]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Ebola virus disease (EVD) continues to be a significant public health problem in sub-Saharan Africa, especially in the Democratic Republic of the Congo (DRC). Large-scale vaccination during outbreaks may reduce virus transmission. We established a large population-based clinical trial of a heterologous, two-dose prophylactic vaccine during an outbreak in eastern DRC to determine vaccine effectiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This open-label, non-randomised, population-based trial enrolled eligible adults and children aged 1\u2009year and above. Participants were offered the two-dose candidate EVD vaccine regimen VAC52150 (Ad26.ZEBOV, Modified Vaccinia Ankara (MVA)-BN-Filo), with the doses being given 56 days apart. After vaccination, serious adverse events (SAEs) were passively recorded until 1\u2009month post dose 2. 1000 safety subset participants were telephoned at 1\u2009month post dose 2 to collect SAEs. 500 pregnancy subset participants were contacted to collect SAEs at D7 and D21 post dose 1 and at D7, 1\u2009month, 3 months and 6 months post dose 2, unless delivery was before these time points. The first 100 infants born to these women were given a clinical examination 3 months post delivery. Due to COVID-19 and temporary suspension of dose 2 vaccinations, at least 50 paediatric and 50 adult participants were enrolled into an immunogenicity subset to examine immune responses following a delayed second dose. Samples collected predose 2 and at 21 days post dose 2 will be tested using the Ebola viruses glycoprotein Filovirus Animal Non-Clinical Group ELISA. For qualitative research, in-depth interviews and focus group discussions were being conducted with participants or parents\/care providers of paediatric participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Approved by Comit\u00e9 National d\u2019Ethique et de la Sant\u00e9 du Minist\u00e8re de la sant\u00e9 de RDC, Comit\u00e9 d'Ethique de l'Ecole de Sant\u00e9 Publique de l\u2019Universit\u00e9 de Kinshasa, the LSHTM Ethics Committee and the MSF Ethics Review Board. Findings will be presented to stakeholders and conferences. Study data will be made available for open access.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04152486\">NCT04152486<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-055596","type":"journal-article","created":{"date-parts":[[2022,3,8]],"date-time":"2022-03-08T11:52:47Z","timestamp":1646740367000},"page":"e055596","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":31,"title":["Protocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04152486","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04152486","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04152486","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6247-1746","authenticated-orcid":false,"given":"Deborah","family":"Watson-Jones","sequence":"first","affiliation":[{"name":"London School of Hygiene & Tropical Medicine, London, UK"},{"name":"Mwanza Intervention Trials Unit, Mwanza, Tanzania, United Republic of"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugo","family":"Kavunga-Membo","sequence":"additional","affiliation":[{"name":"L\u2019Institut National de Recherche Biom\u00e9dicale, Goma, Democratic Republic of the Congo"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca F","family":"Grais","sequence":"additional","affiliation":[{"name":"Epicentre, Paris, \u00cele-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Ahuka","sequence":"additional","affiliation":[{"name":"L\u2019Institut National de Recherche Biom\u00e9dicale, Goma, Democratic Republic of the Congo"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalie","family":"Roberts","sequence":"additional","affiliation":[{"name":"MSF, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W John","family":"Edmunds","sequence":"additional","affiliation":[{"name":"London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8148-120X","authenticated-orcid":false,"given":"Edward M","family":"Choi","sequence":"additional","affiliation":[{"name":"London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chrissy H","family":"Roberts","sequence":"additional","affiliation":[{"name":"London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6110-014X","authenticated-orcid":false,"given":"Tansy","family":"Edwards","sequence":"additional","affiliation":[{"name":"London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anton","family":"Camacho","sequence":"additional","affiliation":[{"name":"Epicentre, Paris, \u00cele-de-France, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelley","family":"Lees","sequence":"additional","affiliation":[{"name":"London School of Hygiene & Tropical Medicine, London, 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