Controlled human infection models can be helpful to study pathogenesis and immune responses as a basis for the development of vaccines. In controlled human infection models, human challenge agents are used to infect healthy volunteers, therefore, ethical considerations include that the exposure studies need to be safe and results should be meaningful, e.g. contribute to a better cure. Both in the US and in Europe, the level of Good Manufacturing Practice required is related to the phase of the study (‘sliding scale Good Manufacturing Practice’), and, hence, is much more open to speedy drug development than anticipated.

Recommendations included: the development of guidelines for human challenge agents; a focus on strain selection, in particular with regard to strain infectivity, stability and purity; the use of whole genome sequencing; a reference repository of challenge agents, the need for early exchange with regulators to ensure acceptability of strain selection and manufacturing for later drug development; sharing of models and challenge agents.

受控的人类感染模型可以有助于研究发病机理和免疫应答，并将其作为开发疫苗的基础。在受控的人类感染模型中，人类挑战剂用于感染健康的志愿者，因此，从伦理角度考虑，暴露研究需要安全并且结果应有意义，例如有助于更好地治愈。在美国和欧洲，所需的良好制造规范水平都与研究阶段有关（“滑动规模良好制造规范”），因此，对快速药物开发的开放性超出了预期。

建议包括：为人类挑战者制定指导方针；专注于菌株的选择，特别是在菌株感染性，稳定性和纯度方面；使用全基因组测序；挑战剂的参考资料库，需要与监管机构及早交换以确保菌株选择和生产的可接受性，以便以后进行药物开发；共享模型和挑战代理商。