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Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
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The human body harbors a vast and diverse viral community known as the human virome. The virome includes bacteriophages that infect bacteria, and eukaryotic viruses that infect human cells. Transient dietary and environmental viruses also contribute to this dynamic ecosystem. Estimates suggest the human body may contain on the order of 10¹³ viral particles, though abundance varies widely by body site and detection method.Comprehensive characterization of the virome has become possible...
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控制的人类感染研究加速疫苗开发

Matthew B Laurens1

  • 1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland 21218, USA.

The Journal of infectious diseases
|January 29, 2025
PubMed
概括

控制的人类感染模型 (CHIM) 通过提供快速的疗效读数来加速疫苗开发. 然而,确保CHIM研究与现实世界的疗效试验相关,尤其是在资源有限的环境中,仍然是一个关键的挑战.

科学领域:

  • 传染病研究传染病研究.
  • 疫苗学 疫苗学 疫苗学
  • 临床试验方法论 临床试验方法论

背景情况:

  • 控制的人类感染模型 (CHIM) 越来越多地被用于疫苗开发.
  • CHIM已应用于30多种疾病模型,显示出快速的进展.
  • 这些模型涉及参与者在服用研究产品后对病原体的受控暴露.

研究的目的:

  • 突出CHIMs在加速疫苗开发方面的优势.
  • 讨论CHIM在降低产品投资风险和确定相关保护方面的关键作用.
  • 识别和解决与CHIM研究相关性和可比性与疗效试验相关的挑战.

主要方法:

  • 审查现有的文献和网络支持的关于CHIMs的研究.
  • 对受控人类感染模型的好处和局限性的分析.
  • 检查CHIM结果与大规模疗效试验的可比性.

主要成果:

  • CHIM提供了疫苗疗效的快速读取,显著加快了开发时间表.
  • 这些研究有助于确定保护和降低投资风险的相关性.
  • 一个重大挑战在于提高CHIM研究结果与流行地区的疗效试验的相关性和可比性.
关键词:
挑战 挑战 挑战 挑战临床试验临床试验临床试验临床试验临床试验控制的人类感染模型

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结论:

  • CHIM是推动众多病原体疫苗开发的强大工具.
  • 需要进一步的工作来弥合CHIM研究结果与不同环境中的现实世界疗效之间的差距.
  • 解决相关性和可比性方面的挑战对于最大限度地提高CHIM的影响至关重要,特别是在资源有限的地区.