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Lessons learnt from the first controlled human malaria infection study conducted in Nairobi, Kenya

机译：从在肯尼亚内罗毕进行的首次人类疟疾控制研究的经验教训

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Background Controlled human malaria infection (CHMI) studies, in which healthy volunteers are infected with Plasmodium falciparum to assess the efficacy of novel malaria vaccines and drugs, have become a vital tool to accelerate vaccine and drug development. CHMI studies provide a cost-effective and expeditious way to circumvent the use of large-scale field efficacy studies to deselect intervention candidates. However, to date few modern CHMI studies have been performed in malaria-endemic countries. Methods An open-label, randomized pilot CHMI study was conducted using aseptic, purified, cryopreserved, infectious P. falciparum sporozoites (SPZ) (Sanaria? PfSPZ Challenge) administered intramuscularly (IM) to healthy Kenyan adults (n?=?28) with varying degrees of prior exposure to P. falciparum. The purpose of the study was to establish the PfSPZ Challenge CHMI model in a Kenyan setting with the aim of increasing the international capacity for efficacy testing of malaria vaccines and drugs, and allowing earlier assessment of efficacy in a population for which interventions are being developed. This was part of the EDCTP-funded capacity development of the CHMI platform in Africa. Discussion This paper discusses in detail lessons learnt from conducting the first CHMI study in Kenya. Issues pertinent to the African setting, including community sensitization, consent and recruitment are considered. Detailed reasoning regarding the study design (for example, dose and route of administration of PfSPZ Challenge, criteria for grouping volunteers according to prior exposure to malaria and duration of follow-up post CHMI) are given and changes other centres may want to consider for future studies are suggested. Conclusions Performing CHMI studies in an African setting presents unique but surmountable challenges and offers great opportunity for acceleration of malaria vaccine and drug development. The reflections in this paper aim to aid other centres and partners intending to use the CHMI model in Africa.
机译：背景技术受控的人类疟疾感染（CHMI）研究已使健康志愿者感染了恶性疟原虫，以评估新型疟疾疫苗和药物的疗效，这已成为加速疫苗和药物开发的重要工具。 CHMI研究提供了一种经济高效且快捷的方法，可避免使用大规模现场功效研究来取消选择干预对象。但是，迄今为止，在疟疾流行国家很少进行现代CHMI研究。方法采用无菌，纯化，冷冻保存的，传染性的恶性疟原虫子孢子虫（Sanaria？PfSPZ Challenge）对健康的肯尼亚成年人（n == 28）进行肌肉注射（IM），进行了开放标签，随机先导CHMI研究。事先暴露于恶性疟原虫的程度不同。这项研究的目的是在肯尼亚环境中建立PfSPZ Challenge CHMI模型，以提高国际上对疟疾疫苗和药物进行功效测试的能力，并允许对正在制定干预措施的人群进行早期功效评估。这是EDCTP资助的非洲CHMI平台能力建设的一部分。讨论本文详细讨论了从在肯尼亚进行的第一项CHMI研究获得的经验教训。考虑了与非洲环境有关的问题，包括社区意识，同意和招募。给出了有关研究设计的详细理由（例如，PfSPZ挑战的剂量和给药途径，根据先前的疟疾暴露水平和CHMI随访时间将志愿者分组的标准），以及其他中心可能希望考虑的变化建议进行研究。结论在非洲环境中进行CHMI研究面临独特但可克服的挑战，并为加速疟疾疫苗和药物开发提供了巨大的机会。本文的思考旨在帮助打算在非洲使用CHMI模型的其他中心和合作伙伴。

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