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类鼻疽疫苗(MeVa):泰国乌汶府关键利益相关者对疫苗、类鼻疽及临床试验的态度

Melioidosis Vaccines (MeVa): Attitudes to vaccines, melioidosis and clinical trials in key stakeholders in Ubon Ratchathani, Thailand.

作者信息

Khirikoekkong Napat, Asarath Supa-At, Hill Jennifer, Wettana Benjawan, Srisawang Orathai, Cheah Phaik Yeong, Dunachie Susanna, Chamnan Parinya

机构信息

Mahidol Oxford Tropical Medicine Research Unit, Bangkok, 10400, Thailand.

NIHR Oxford Biomedical Research Centre, Oxford University Hospitals Trust, Oxford, UK.

出版信息

Wellcome Open Res. 2023 Sep 19;8:413. doi: 10.12688/wellcomeopenres.18383.1. eCollection 2023.

Abstract

Melioidosis is a bacterial infection which kills an estimated 89,000 people per year in tropical and sub-tropical regions, chiefly affecting the poorest. Diabetes is the primary risk factor, conferring a 12-fold increase in risk. Despite limited funding compared to other neglected tropical diseases, melioidosis vaccine development has generated several candidates for clinical development. CPS-CRM /Hcp1 is a promising vaccine candidate developed at the University of Nevada, Reno which is due to enter a Phase I clinical trial in Oxford, UK in 2024. As we move closer to the possibility of field trials of a melioidosis vaccine, it is critical to work in parallel to understand perceptions toward a vaccine among those living where melioidosis rates are high. Reasons for vaccine acceptance versus hesitancy are complex, and include perceived risk of the target disease, concern about side effects, and above all trust in government, scientists, the pharmaceutical industry and other authorities. We will carry out a qualitative study in Ubon Ratchathani, Thailand, an endemic region for melioidosis, as groundwork for a potential future melioidosis vaccine efficacy study, and in the longer-term vaccine introduction. This study seeks to explore knowledge and attitudes in three main areas; 1) melioidosis disease, 2) vaccines, and 3) participation in clinical vaccine trials. In-depth interviews and focus group discussions will take place in five participant groups of different risks and exposure to melioidosis. Purposive, convenience sampling will be used, also snowball sampling to reach some participant groups. Sample size will be based on participant's experience, to inform the line of enquiries of study, or until data saturation, expecting 66-90 participants across all groups. The findings of this study will be written up and published in an open access journal, and will be valuable to inform future design of clinical trials as well as engagement and communications associated with future vaccine rollout.

摘要

类鼻疽是一种细菌感染病,在热带和亚热带地区每年导致约8.9万人死亡,主要影响最贫困人群。糖尿病是主要风险因素,会使患病风险增加12倍。尽管与其他被忽视的热带病相比资金有限,但类鼻疽疫苗研发已产生了几种有望进入临床开发阶段的候选疫苗。CPS-CRM/Hcp1是内华达大学雷诺分校研发的一种很有前景的候选疫苗,将于2024年在英国牛津进入I期临床试验。随着我们越来越接近开展类鼻疽疫苗现场试验的可能性,与此同时了解类鼻疽发病率高的地区居民对疫苗的看法至关重要。接受疫苗与犹豫接种的原因很复杂,包括对目标疾病的感知风险、对副作用的担忧,以及最重要的是对政府、科学家、制药行业和其他权威机构的信任。我们将在泰国乌汶府进行一项定性研究,该地区是类鼻疽的流行区,作为未来潜在的类鼻疽疫苗疗效研究以及长期疫苗推广的基础工作。本研究旨在探索三个主要领域的知识和态度:1)类鼻疽疾病,2)疫苗,3)参与临床疫苗试验。将在五个不同风险和接触类鼻疽情况的参与者群体中进行深入访谈和焦点小组讨论。将采用立意抽样、便利抽样,也会采用滚雪球抽样来接触一些参与者群体。样本量将根据参与者的经验确定,以指导研究的询问方向,或直至数据饱和,预计所有群体共有66 - 90名参与者。本研究的结果将撰写并发表在一本开放获取期刊上,对于为未来临床试验的设计以及与未来疫苗推广相关的参与和沟通提供信息将具有重要价值。

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本文引用的文献

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Factors associated with COVID-19 Vaccine Hesitancy in Thai Seniors.泰国老年人中与新冠疫苗犹豫相关的因素。
Patient Prefer Adherence. 2021 Oct 31;15:2389-2403. doi: 10.2147/PPA.S334757. eCollection 2021.
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