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Title

Volunteer feedback and perceptions after participation in a phase I, first-in-human Ebola vaccine trial: An anonymous survey

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Published in PLOS ONE. 2017, vol. 12, no. 3, p. e0173148
Abstract The continued participation of volunteers in clinical trials is crucial to advances in healthcare. Few data are available regarding the satisfaction and impressions of healthy volunteers after participation in phase I trials, many of which lead to unexpected adverse events. We report feedback from over 100 adult volunteers who took part in a first-in-human trial conducted in a high-income country testing an experimental Ebola vaccine causing significant reactogenicity, as well as unexpected arthritis in one fifth of participants. The anonymous, internet-based satisfaction survey was sent by email to all participants upon their completion of this one-year trial; it asked 24 questions concerning volunteers' motivations, impressions of the trial experience, and overall satisfaction. Answers were summarized using descriptive statistics. Of the 115 trial participants, 103 (90%) filled out the survey. Fifty-five respondents (53%) were male. Thirty-five respondents (34%) were healthcare workers, many of whom would deploy to Ebola-affected countries. All respondents cited scientific advancement as their chief motivation for participation, while 100/103 (97%) and 61/103 (59%) reported additional "humanitarian reasons" and potential protection from Ebolavirus, respectively. Although investigators had documented adverse events in 97% of trial participants, only 74 of 103 respondents (72%) recalled experiencing an adverse event. All reported an overall positive experience, and 93/103 (90%) a willingness to participate in future trials. Given the high level of satisfaction, no significant associations could be detected between trial experiences and satisfaction, even among respondents reporting adverse events lasting weeks or months. Despite considerable reactogenicity and unexpected vaccine-related arthritis, all survey respondents reported overall satisfaction. While this trial's context was unique, the positive feedback is likely due at least in part to the intense communication of trial information to participants, which included both general findings and personalized results.
Keywords AdolescentAdultAgedEbola Vaccines/administration & dosage/adverse effects/immunologyEbolavirus/immunologyFeedbackFemaleHemorrhagic Fever, Ebola/prevention & controlHumansMaleMiddle AgedPatient Outcome AssessmentPerceptionSelf ReportSocioeconomic FactorsSurveys and QuestionnairesVolunteersYoung Adult
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PMID: 28273130
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Article (Published version) (1.2 MB) - public document Free access
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Research groups Centre de vaccinologie et d'immunologie néonatale (177)
Groupe Harbarth Stephan (Staphylocoques dorés résistants à la méthicilline) (866)
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DAYER, Julie-Anne, SIEGRIST, Claire-Anne, CSAKI HUTTNER, Angela. Volunteer feedback and perceptions after participation in a phase I, first-in-human Ebola vaccine trial: An anonymous survey. In: PLOS ONE, 2017, vol. 12, n° 3, p. e0173148. doi: 10.1371/journal.pone.0173148 https://archive-ouverte.unige.ch/unige:99544

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Deposited on : 2017-11-23

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