Clinical Trial Center, INSERM CIC 1408, University Hospital of Saint-Etienne, 42055 Saint-Etienne, France; Groupe Immunité Muqueuse et Agents Pathogènes (GIMAP), EA3064 - Medical School of Saint-Etienne, University of Lyon, France; Inserm, F-CRIN, Innovative Clinical Research Network in Vaccinology (I-REIVAC), Paris, France.
Inserm, F-CRIN, Innovative Clinical Research Network in Vaccinology (I-REIVAC), Paris, France; Université Paris Descartes, Sorbonne Paris Cité, France; Inserm, CIC 1417, Assistance Publique-Hôpitaux de Paris, CIC Cochin Pasteur, Hôpital Cochin Broca Hôtel-Dieu, Paris, France.
Vaccine. 2019 Oct 16;37(44):6633-6639. doi: 10.1016/j.vaccine.2019.09.048. Epub 2019 Sep 19.
Recruitment in preventive vaccine trials (PVT) is challenging due to common barriers to clinical research and lack of vaccine confidence. Identifying determinants of participation can help to improve recruitment. A prospective survey was conducted in 5 French clinical investigational sites. People asked to participate in a PVT were given a questionnaire whether they decided to participate or not in the trial. A total of 341 people answered the survey: 210 accepting and 131 declining to participate in a PVT. Acceptors were significantly younger (38.5 vs 54.9 years old), more likely to be involved in early phase trials, had a higher level of education (p < 0.005) and a significantly better general opinion concerning vaccines (92.3% versus 72.3%, p < 0.005) compared with those who declined. Factors associated with acceptance or refusal were evaluated in 224 people in the 4 sites where both groups were included. In a multivariate analysis, three factors: older age, having heard about PVT through multiple sources and financial incentives were significantly associated with refusal to participate in the PVT. A generally favourable opinion of vaccines was associated with acceptance. The main motivation for participation was altruism (93.2%) whereas fear of side effects was at the forefront of the barriers (36.6%). Information given by the physician was a key point for decision-making in 70.2% of those who accepted. In brief, vaccine hesitancy may decrease recruitment in PVTs; reinforcing altruism and quality of information given are key points in acceptance of participation in PVT.
在预防性疫苗试验 (PVT) 中，由于临床研究的常见障碍和对疫苗缺乏信心，招募工作具有挑战性。确定参与的决定因素有助于提高招募效果。在法国的 5 个临床研究机构进行了一项前瞻性调查。要求参与 PVT 的人填写一份问卷，以了解他们是否决定参加或不参加试验。共有 341 人回答了调查：210 人接受，131 人拒绝参加 PVT。接受者明显更年轻（38.5 岁与 54.9 岁），更有可能参与早期阶段的试验，教育程度更高（p<0.005），对疫苗的总体评价也明显更好（92.3%与 72.3%，p<0.005）。在包含接受者和拒绝者的 4 个研究点中，对 224 人进行了接受或拒绝的因素评估。在多变量分析中，3 个因素：年龄较大、通过多种途径听说过 PVT 和经济激励与拒绝参与 PVT 显著相关。对疫苗的普遍好评与接受有关。参与的主要动机是利他主义（93.2%），而对副作用的恐惧是最大的障碍（36.6%）。接受者中 70.2%的人认为医生提供的信息是决策的关键。总之，疫苗犹豫可能会降低 PVT 的招募效果；增强利他主义和提供的信息质量是接受 PVT 参与的关键要点。
