严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）人类感染对照模型：伦理、挑战病原体生产及监管问题
SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues.
作者信息
Baay Marc, Neels Pieter
机构信息
P95 Epidemiology & Pharmacovigilance, Leuven, Belgium.
International Alliance for Biological Standardization - IABS, Geneva, Switzerland.
出版信息
Biologicals. 2020 Sep;67:69-74. doi: 10.1016/j.biologicals.2020.08.006. Epub 2020 Aug 15.
Abstract
This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
摘要
第二届国际生物标准化联盟新冠病毒网络研讨会汇聚了众多国际利益相关者，包括学术界、监管机构、资助者和行业代表，低收入和中等收入国家也有大量人员参与，共同探讨如何利用人类感染对照模型来加速针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗的研发及上市许可评估。
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本文引用的文献
1
Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.COVID-19 人体挑战研究的伦理可接受性的关键标准：世卫组织工作组的报告。
Vaccine. 2021 Jan 22;39(4):633-640. doi: 10.1016/j.vaccine.2020.10.075. Epub 2020 Oct 28.
2
SARS-CoV-2: Virology, epidemiology, immunology and vaccine development.严重急性呼吸综合征冠状病毒2：病毒学、流行病学、免疫学与疫苗研发
Biologicals. 2020 Jul;66:35-40. doi: 10.1016/j.biologicals.2020.06.005. Epub 2020 Jun 23.
3
Genomewide Association Study of Severe Covid-19 with Respiratory Failure.全基因组关联研究严重新冠肺炎伴呼吸衰竭。
N Engl J Med. 2020 Oct 15;383(16):1522-1534. doi: 10.1056/NEJMoa2020283. Epub 2020 Jun 17.
4
COVID-19 human challenge studies: ethical issues.COVID-19 人体挑战研究：伦理问题。
Lancet Infect Dis. 2020 Aug;20(8):e198-e203. doi: 10.1016/S1473-3099(20)30438-2. Epub 2020 May 29.
5
Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.人类挑战试验研讨会：关注挑战剂的质量要求，德国兰根，2019 年 10 月 22 日。
Biologicals. 2020 Jul;66:53-61. doi: 10.1016/j.biologicals.2020.04.005. Epub 2020 May 4.
6
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Science. 2020 May 22;368(6493):832-834. doi: 10.1126/science.abc1076. Epub 2020 May 7.
7
Developing Covid-19 Vaccines at Pandemic Speed.以大流行速度研发新冠疫苗。
N Engl J Med. 2020 May 21;382(21):1969-1973. doi: 10.1056/NEJMp2005630. Epub 2020 Mar 30.
8
Genetic drift of human coronavirus OC43 spike gene during adaptive evolution.人类冠状病毒OC43刺突基因在适应性进化过程中的遗传漂变
Sci Rep. 2015 Jun 22;5:11451. doi: 10.1038/srep11451.
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