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Typhoidal Salmonella human challenge studies: ethical and practical challenges and considerations for low-resource settings

机译：Typhoidal Salmonella人类挑战研究：低资源环境的道德和实际挑战和考虑因素

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Typhoidal Salmonella is a major global problem affecting more than 12 million people annually. Controlled human infection models (CHIMs) in high-resource settings have had an important role in accelerating the development of conjugate vaccines against Salmonella Typhi.The typhoidal Salmonella model has an established safety profile in over 2000 volunteers in high-income settings, and trial protocols, with modification, could be readily transferred to new study sites. To date, a typhoidal Salmonella CHIM has not been conducted in a low-resource setting, although it is being considered.Our article describes the challenges posed by a typhoidal Salmonella CHIM in the high-resource setting of Oxford and explores considerations for an endemic setting.Development of CHIMs in endemic settings is scientifically justifiable as it remains unclear whether findings from challenge studies performed in high-resource non-endemic settings can be extrapolated to endemic settings, where the burden of invasive Salmonella is highest. Volunteers are likely to differ across a range of important variables such as previous Salmonella exposure, diet, intestinal microbiota, and genetic profile. CHIMs in endemic settings arguably are ethically justifiable as affected communities are more likely to gain benefit from the study. Local training and research capacity may be bolstered.Safety was of primary importance in the Oxford model. Risk of harm to the individual was mitigated by careful inclusion and exclusion criteria; close monitoring with online diary and daily visits; 24/7 on-call staffing; and access to appropriate hospital facilities with capacity for in-patient admission. Risk of harm to the community was mitigated by exclusion of participants with contact with vulnerable persons; stringent hygiene and sanitation precautions; and demonstration of clearance of Salmonella infection from stool following antibiotic treatment.Safety measures should be more stringent in settings where health systems, transport networks, and sanitation are less robust.We compare the following issues between high- and low-resource settings: scientific justification, risk of harm to the individual and community, benefits to the individual and community, participant understanding, compensation, and regulatory requirements.We conclude that, with careful consideration of country-specific ethical and practical issues, a typhoidal Salmonella CHIM in an endemic setting is possible.
机译：Typhoidal Salmonella是一家每年影响超过1200万人的主要问题。高资源环境中的受控人体感染模型（Chims）在加速对沙门氏菌Typhi的缀合物疫苗的发展方面具有重要作用。Typhoidal Salmonella模型在高收入设置和试验方案中拥有2​​000多个志愿者的安全性。随着修改，可以随时转移到新的研究网站。迄今为止，虽然正在考虑，但是在低资源环境中尚未在低资源环境中进行牙膏沙门氏菌。我们文章介绍了在牛津的高资源环境中造成伤寒沙门氏菌的挑战，并探讨了地方性环境的考虑因素。奇姆斯在流行的环境中的发展是科学上的合理性，因为它仍然尚不清楚在高资源非特有环境中进行的挑战研究的结果是否可以推断为流动的环境，侵袭性沙门氏菌的负担最高。志愿者可能在一系列重要的变量中不同，例如先前的沙门氏菌暴露，饮食，肠道微生物群和遗传概况。由于受影响的社区更有可能从研究中获得受益的情况，可以说是民道理的，可以说是道德地合理的。本地培训和研究能力可能是助长的。安全在牛津模型中具有初步意义。通过仔细包容和排除标准，减轻了对个人伤害的危险;密切监测在线日记和每日访问; 24/7随叫随到的人员配置;并获得适当的医院设施，具有内在内部入住的能力。通过与弱势群体的联系排除参与者，减轻了社会危害的风险;严格的卫生和卫生预防措施;抗生素治疗后粪便中沙门氏菌感染的清除的证明。安全系统，运输网络和卫生的环境中的安全措施更加严格，在稳健的情况下，我们比较高资源环境之间的以下问题：科学理由，对个人和社区造成伤害的危险，对个人和社区的利益，参与者的理解，赔偿和监管要求。我们得出结论，仔细考虑到国家特定的道德和实际问题，一种胸腺沙门氏菌在地方性环境中是可能的。

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