{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T14:15:23Z","timestamp":1778681723539,"version":"3.51.4"},"reference-count":14,"publisher":"Elsevier BV","issue":"24","license":[{"start":{"date-parts":[[2020,5,1]],"date-time":"2020-05-01T00:00:00Z","timestamp":1588291200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,5,1]],"date-time":"2020-05-01T00:00:00Z","timestamp":1588291200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2020,4,4]],"date-time":"2020-04-04T00:00:00Z","timestamp":1585958400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Norwegian Institute of Public Health","award":["108016-005"],"award-info":[{"award-number":["108016-005"]}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Vaccine"],"published-print":{"date-parts":[[2020,5]]},"DOI":"10.1016\/j.vaccine.2020.03.015","type":"journal-article","created":{"date-parts":[[2020,4,11]],"date-time":"2020-04-11T01:02:46Z","timestamp":1586566966000},"page":"4050-4056","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":3,"title":["Arranging good clinical practices training and trial monitoring for a vaccine efficacy study during a public health emergency of international concern"],"prefix":"10.1016","volume":"38","author":[{"given":"Milagritos D.","family":"Tapia","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moussa","family":"Doumbia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rokiatou","family":"Dembele","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Ball","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birahim","family":"N'Diaye","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haoua","family":"Amadou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Charara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana Maria","family":"Henao-Restrepo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corinne S.","family":"Merle","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samba O.","family":"Sow","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Myron M.","family":"Levine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"issue":"Suppl 3","key":"10.1016\/j.vaccine.2020.03.015_b0005","doi-asserted-by":"crossref","first-page":"S785","DOI":"10.1093\/infdis\/jir298","article-title":"Management of accidental exposure to Ebola virus in the biosafety level 4 laboratory, Hamburg, Germany","volume":"204","author":"Gunther","year":"2011","journal-title":"J Infect Dis"},{"issue":"7","key":"10.1016\/j.vaccine.2020.03.015_b0010","doi-asserted-by":"crossref","first-page":"859","DOI":"10.1517\/14712598.2012.685152","article-title":"Current ebola vaccines","volume":"12","author":"Hoenen","year":"2012","journal-title":"Expert Opin Biol Ther"},{"issue":"5","key":"10.1016\/j.vaccine.2020.03.015_b0015","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1038\/nrmicro2129","article-title":"Correlates of protective immunity for Ebola vaccines: implications for regulatory approval by the animal rule","volume":"7","author":"Sullivan","year":"2009","journal-title":"Nat Rev Microbiol"},{"issue":"Apr","key":"10.1016\/j.vaccine.2020.03.015_b0020","article-title":"Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe - Preliminary Report","author":"Agnandji","year":"2015","journal-title":"N Engl J Med"},{"key":"10.1016\/j.vaccine.2020.03.015_b0025","doi-asserted-by":"crossref","unstructured":"Tapia MD, Sow SO, Lyke KE, et al. Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis 2015 Nov 3;dx.doi.org\/10.1016\/S1473-3099(15)00362-X.","DOI":"10.1016\/S1473-3099(15)00362-X"},{"issue":"1","key":"10.1016\/j.vaccine.2020.03.015_b0030","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1177\/1740774515621037","article-title":"Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges","volume":"13","author":"Kennedy","year":"2016","journal-title":"Clin Trials"},{"issue":"3","key":"10.1016\/j.vaccine.2020.03.015_b0035","doi-asserted-by":"crossref","first-page":"98","DOI":"10.15585\/mmwr.su6503a14","article-title":"Implementing an Ebola Vaccine Study - Sierra Leone","volume":"65","author":"Widdowson","year":"2016","journal-title":"MMWR Suppl"},{"key":"10.1016\/j.vaccine.2020.03.015_b0040","first-page":"10","article-title":"Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial","volume":"15","author":"Henao-Restrepo","year":"2015","journal-title":"Lancet"},{"issue":"48","key":"10.1016\/j.vaccine.2020.03.015_b0045","doi-asserted-by":"crossref","first-page":"7171","DOI":"10.1016\/j.vaccine.2018.09.009","article-title":"Safety of the rVSV ZEBOV vaccine against Ebola Zaire among frontline workers in Guinea","volume":"37","author":"Juan-Giner","year":"2019","journal-title":"Vaccine"},{"issue":"10068","key":"10.1016\/j.vaccine.2020.03.015_b0050","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1016\/S0140-6736(16)32621-6","article-title":"Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ca Suffit!)","volume":"389","author":"Henao-Restrepo","year":"2017","journal-title":"Lancet"},{"issue":"12","key":"10.1016\/j.vaccine.2020.03.015_b0055","doi-asserted-by":"crossref","first-page":"1276","DOI":"10.1016\/S1473-3099(17)30541-8","article-title":"Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report","volume":"17","author":"Gsell","year":"2017","journal-title":"Lancet Infect Dis"},{"issue":"20","key":"10.1016\/j.vaccine.2020.03.015_b0060","doi-asserted-by":"crossref","first-page":"10178","DOI":"10.1073\/pnas.1817329116","article-title":"Ebola vaccination in the Democratic Republic of the Congo","volume":"116","author":"Wells","year":"2019","journal-title":"Proc Natl Acad Sci USA"},{"issue":"7783","key":"10.1016\/j.vaccine.2020.03.015_b0065","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1038\/d41586-019-03490-8","article-title":"'Make Ebola a thing of the past': first vaccine against deadly virus approved","volume":"575","author":"Callaway","year":"2019","journal-title":"Nature"},{"key":"10.1016\/j.vaccine.2020.03.015_b0070","unstructured":"FDA. FDA News Release -- First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response. US Food and Drug Administration; 2019 Dec 19."}],"container-title":["Vaccine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X20303595?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X20303595?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T13:31:36Z","timestamp":1778679096000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0264410X20303595"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5]]},"references-count":14,"journal-issue":{"issue":"24","published-print":{"date-parts":[[2020,5]]}},"alternative-id":["S0264410X20303595"],"URL":"https:\/\/doi.org\/10.1016\/j.vaccine.2020.03.015","relation":{},"ISSN":["0264-410X"],"issn-type":[{"value":"0264-410X","type":"print"}],"subject":[],"published":{"date-parts":[[2020,5]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Arranging good clinical practices training and trial monitoring for a vaccine efficacy study during a public health emergency of international concern","name":"articletitle","label":"Article Title"},{"value":"Vaccine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2020.03.015","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2017.10.111","name":"associatedlink","label":"CrossRef DOI link to the associated document"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2017.09.094","name":"associatedlink","label":"CrossRef DOI link to the associated document"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2019.09.094","name":"associatedlink","label":"CrossRef DOI link to the associated document"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2018.09.009","name":"associatedlink","label":"CrossRef DOI link to the associated document"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2017.08.058","name":"associatedlink","label":"CrossRef DOI link to the associated document"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2020 The Authors. Published by Elsevier Ltd.","name":"copyright","label":"Copyright"}]}}