Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis.
Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis.
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DOI：
10.1186/s40900-021-00277-y
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发表时间：
2021-05-30
影响因子：
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通讯作者：
Lacey CJ
中科院分区：
文献类型：
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作者：
Parkash V;Jones G;Martin N;Steigmann M;Greensted E;Kaye P;Layton AM;Lacey CJ
受控人类感染模型(CHIM)包括让志愿者故意接触病原体，以评估他们在开发的早期阶段对新疗法的反应。我们在这里展示了我们如何利用公众参与来帮助塑造CHIM的设计，以支持未来对被忽视的热带疾病皮肤利什曼病候选疫苗的测试，皮肤利什曼病是一种通过热带地区受感染的沙蝇叮咬传播的疾病。我们进行了公众参与(PI)咨询工作，以便为一项研究的进展提供信息，该研究旨在测试使用未受感染的沙蝇(FLYBITE：ClinicalTrials.gov ID NCT03999970)和使用重大感染利什曼原虫的沙蝇(LEISH_Challenger：ClinicalTrials.gov ID NCT04512742)咬沙蝇方案的安全性和有效性，这两项研究都在英国约克进行。我们参与了10名公众，其中包括一名患者研究大使和一名之前的Chim志愿者。会议在英国约克大学举行，审查了面向志愿者的研究材料草案，包括CHIM研究设计、潜在的不良事件和研究终点的治疗干预。向与会者介绍了该项目的科学、伦理、人道主义和经济基础的讨论，以引起讨论。采用归纳性的主题分析来确定参与者的主要关切。确定的主题涉及：1)面向志愿者的书面信息的质量；2)改进研究设计；3)激励参与研究的因素。小组参与者对总体研究目标做出了积极的回应。最初表达了对参与研究的潜在风险的担忧，但对风险的科学和缓解的进一步解释确保了参与者的支持。与会者提供了建议，并确定了改进后的术语，以便为面向志愿人员的材料提供信息。最后，讨论了治疗方案，作为一种治疗方案，任何皮肤病变的切除都是最受欢迎的。咨询工作提供了宝贵的信息，从而改进了研究设计，提高了面向志愿人员的材料的清晰度。会议还强调，在开始任何研究之前，必须保持公众对科学严谨性的信任。研究人员希望这一描述在临床研究中加强对PI的理解，并鼓励在其他研究中使用它。网上版载有补充材料，可在10.1186/s40900-021-00277-y查阅。我们的研究团队正在设计一种被称为受控人类感染模型(CHIM)的研究。在CHIM研究中，志愿者被故意暴露在感染中，然后进行研究以帮助了解疾病。类似的实验，即人类被故意感染，数百年来一直被用来帮助测试治疗方法。最近，CHIM研究已经被用于帮助测试疟疾等疾病的疫苗。利什曼病是一种每年影响数百万人的疾病，在热带国家通过受感染的沙蝇叮咬传播。目前还没有可供人类使用的利什曼病疫苗。人们认为，通过使用CHIM研究，新疫苗可能会更快地进行测试并获得批准。科学研究人员对CHIM研究的用处进行了多次讨论，特别是在其背后的科学、志愿者的安全和这些研究的伦理方面。研究人员也明白，让公众参与设计和开展研究，特别是涉及人类的研究，以获得独立的观点是多么重要。因此，在设计这项研究的某些部分，我们让公众参与了一次小组讨论。我们还包括一名已经参加了另一项CHIM研究的人。这些讨论产生了重要影响，并改变了我们计划开展未来研究的方式。我们也希望这一描述将鼓励其他研究人员在规划未来研究时将公众包括在内。网上版载有补充材料，可在10.1186/s40900-021-00277-y查阅。
A controlled human infection model (CHIM) involves deliberate exposure of volunteers to pathogens to assess their response to new therapies at an early stage of development. We show here how we used public involvement to help shape the design of a CHIM to support future testing of candidate vaccines for the neglected tropical disease cutaneous leishmaniasis, a disease transmitted by the bite of infected sand flies in tropical regions. We undertook a public involvement (PI) consultation exercise to inform development of a study to test the safety and effectiveness of a sand fly biting protocol using uninfected sand flies (FLYBITE: ClinicalTrials.gov ID NCT03999970) and a CHIM using Leishmania major-infected sand flies (LEISH_Challenge: ClinicalTrials.gov ID NCT04512742), both taking place in York, UK. We involved 10 members of the public including a patient research ambassador and a previous CHIM volunteer. The session took place at The University of York, UK and examined draft study volunteer-facing material and included the CHIM study design, potential adverse events and therapeutic interventions at study endpoints. A discussion of the scientific, ethical, humanitarian and economic basis for the project was presented to the participants to provoke discourse. An inductive, thematic analysis was used to identify the participants’ key concerns. Themes were identified relating to i) quality of volunteer-facing written information, ii) improving study design, and iii) factors to motivate involvement in the research. Group participants responded positively to the overall study aims. Initial concerns were expressed about potential risks of study involvement, but further explanation of the science and mitigations of risk secured participant support. Participants provided advice and identified improved terminology to inform the volunteer-facing material. Lastly, treatment options were discussed, and excision of any cutaneous lesion was favoured over alternatives as a treatment. The consultation exercise provided invaluable information which led to improved study design and enhanced clarity in the volunteer-facing material. The session also reinforced the need to maintain public trust in scientific rigour prior to initiation of any study. The investigators hope that this description strengthens understanding of PI in clinical research, and encourages its use within other studies. The online version contains supplementary material available at 10.1186/s40900-021-00277-y. Our research team is designing a type of research study known as a controlled human infection model (CHIM). In CHIM studies, volunteers are exposed to infections on purpose and then studied to help understand diseases. Similar experiments, where humans are infected deliberately, have been used for hundreds of years to help test treatments. CHIM studies have already been used more recently to help test vaccines for diseases such as malaria. The disease leishmaniasis, a disease affecting millions each year, is spread by the bite of an infected sand fly in tropical countries. There are currently no vaccines for leishmaniasis that are available for use in humans. It is thought that by using CHIM studies, new vaccines might be tested and then approved more quickly. Scientific researchers have had many discussions about how useful CHIM studies are, especially in terms of the science behind them, the safety of volunteers and the ethics of these studies. Researchers also understand how important it is to involve the public in designing and carrying out research, especially studies involving humans, to get an independent point-of-view. We have therefore involved the public, in some parts of designing this research, in a group discussion. We also included a person who has already taken part in a different CHIM study. These discussions have had an important effect and have changed how we plan to carry out our future research studies. We also hope that this description will encourage other researchers to include the public when planning future research. The online version contains supplementary material available at 10.1186/s40900-021-00277-y.