Novel Tech Ethics, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Johnson Shoyama Graduate School of Public Policy, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Novel Tech Ethics, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Philosophy, Langara College, Vancouver, British Columbia, Canada.
Vaccine. 2019 Jan 7;37(2):289-295. doi: 10.1016/j.vaccine.2018.11.014. Epub 2018 Dec 7.
INTRODUCTION/HYPOTHESIS: Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014-2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.
An online survey which included participants' prior experience with clinical trials, motivations to participate (including financial incentives), and demographic information was developed to examine the motivations of healthy participants in two phase 1 clinical vaccine trials conducted at the Canadian Center for Vaccinology in Halifax, Nova Scotia. Participants were invited via email to complete the online survey. Readability and clarity were assessed through pilot testing.
A total of 49 (55.7%) of 88 participants of the two studies completed the survey (22 [55%] of 40 participants from the Ebola vaccine study and 27 [56.3%] of 48 from the adjuvanted influenza vaccine study). Motivations that were most frequently ranked among participants' top three in both trials were (1) wanting to contribute to the health of others, (2) wanting to participate in something important, (3) wanting to contribute to the advancement of science, and (4) wanting to receive an incentive such as money or a tablet.
CONCLUSIONS/RECOMMENDATIONS: Although media attention and financial compensation were more often cited by Ebola vaccine trial participants as a reason to participate, both altruistic and self-interested factors were important motivations for participants in their decision to participate in a phase 1 vaccine clinical trial.
简介/假设：由于这些疫苗尚未在人类中使用，并且参与者没有感觉到受益，因此招募参加 1 期疫苗临床试验可能具有挑战性。偶尔，就像 2014-2016 年西非埃博拉病毒爆发期间在加拿大哈利法克斯进行的 1 期埃博拉疫苗临床试验一样，招募工作也不那么困难。在这项研究中，我们探讨了同时在同一中心招募的两项 1 期疫苗试验中参与者的动机，并将高知名度的 1 期埃博拉疫苗试验参与者的动机与知名度较低的 1 期佐剂季节性流感疫苗研究参与者的动机进行了比较。
开发了一项在线调查，其中包括参与者以前参加临床试验的经验，参与动机（包括经济奖励）和人口统计信息，以检查在加拿大哈利法克斯的加拿大疫苗学中心进行的两项 1 期临床疫苗试验中健康参与者的动机。通过电子邮件邀请参与者完成在线调查。通过试点测试评估了可读性和清晰度。
两项研究的 88 名参与者中有 49 名（55.7％）完成了调查（来自埃博拉疫苗研究的 40 名参与者中有 22 名[55％]，来自佐剂流感疫苗研究的 48 名中有 27 名[56.3％]）。在两项试验中，参与者排名前三位的动机是（1）希望为他人的健康做出贡献，（2）希望参与重要的事情，（3）希望为科学的进步做出贡献，以及（4）希望获得奖励，例如金钱或平板电脑。
结论/建议：尽管媒体关注和经济补偿是埃博拉疫苗试验参与者更常被提及的参与原因，但在做出参与 1 期疫苗临床试验的决定时，利他主义和自身利益因素都是参与者的重要动机。
