提示: 手机请竖屏浏览!

加速SARS-CoV-2疫苗研发——受控的人体感染模型的作用
Accelerating Development of SARS-CoV-2 Vaccines — The Role for Controlled Human Infection Models


Meagan E. Deming ... 呼吸系统疾病 • 2020.09.03
相关阅读
• 推进RNA疫苗研发工作 • 以疾病大流行的速度开发针对COVID-19的疫苗

过去20年间的第三次冠状病毒疫情,即SARS-CoV-2大流行已造成前所未有的患病人数、死亡人数和经济破坏。目前亟须安全、有效且可推广的SARS-CoV-2疫苗,从而减轻大流行的后果,并防止未来的暴发。对COVID-19采取的加速应对措施包括对多种候选疫苗的临床前和临床试验以及生产进行投资,而美国的疫苗效力试验预计将于2020年7月启动。

有人提议将受控的人体感染模型(CHIM)作为加速SARS-CoV-2疫苗研发的策略。目前的评论大多侧重于此类模型带来的伦理方面的考虑,评论指出了其所产生的社会效益,同时就风险是否合理提出了一系列观点1-3。他们考虑的争议是基于以下假设:在缺乏COVID-19可靠疗法的世界中,使用SARS-CoV-2有目的地感染(攻击)人体所带来的风险。作为SARS-CoV-2 CHIM推动力的公共卫生职责和在风险合理性方面提出的要求都需要有一个模型来探究一些有价值的问题并给出科学合理的答案。我们代表加速COVID-19治疗干预和疫苗(Accelerating COVID-19 Therapeutic Interventions and Vaccines,ACTIV)工作组,重点关注与SARS-CoV-2 CHIM研发相关的实际考虑因素以及使用此模型的先决条件。





作者信息

Meagan E. Deming, M.D., Ph.D., Nelson L. Michael, M.D., Ph.D., Merlin Robb, M.D., Myron S. Cohen, M.D., and Kathleen M. Neuzil, M.D., M.P.H.
From the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (M.E.D., K.M.N.), the Center for Infectious Diseases Research, Walter Reed Army Institute of Research, Silver Spring (N.L.M.), and the Henry Jackson Foundation, Bethesda (M.R.) — all in Maryland; and the Institute for Global Health and Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill (M.S.C.). Drs. Michael, Robb, Cohen, and Neuzil are members of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Vaccines Working Group, a public–private partnership sponsored by the National Institutes of Health; its other members are Paula Annunziato, M.D., Ann Arvin, M.D., Beth Bell, M.D., Susan Buchbinder, M.D., Marco Cavaleri, Ph.D., Lawrence Corey, M.D., Mark Davis, Ph.D., Emilio Emini, Ph.D., Gregory M. Glenn, M.D., Emmanuel Hanon, Ph.D., Barton Haynes, M.D., Peter Hotez, M.D., Ph.D., Kathrin Jansen, Ph.D. (cochair), Antonio Lanzavecchia, M.D., Douglas R. Lowy, M.D. (cochair), Peter Marks, M.D., Ph.D., John Mascola, M.D., Nancy Messonier, M.D., Nelson Michael, M.D., Ph.D., Paul Offit, M.D., Hanneke Schuitemaker, Ph.D., Jonathan Seals, Ph.D., Jim Tartaglia, Ph.D., and Tal Zaks, M.D., Ph.D.

 

参考文献

1. Eyal N, Lipsitch M, Smith PG. Human challenge studies to accelerate coronavirus vaccine licensure. J Infect Dis 2020;221:1752-1756.

2. Shah SK, Miller FG, Darton TC, et al. Ethics of controlled human infection to address COVID-19. Science 2020;368:832-834.

3. Plotkin SA, Caplan A. Extraordinary diseases require extraordinary solutions. Vaccine 2020;38:3987-3988.

4. World Health Organization Advisory Group on Human Challenge Studies. Feasibility, potential value and limitations of establishing a closely monitored challenge model of experimental COVID-19 infection and illness in healthy young adult volunteers. Geneva: World Health Organization, 2020 (https://www.who.int/publications/m/item/feasibility-potential-value-and-limitations-of-establishing-a-closely-monitored-challenge-model-of-experimental-covid-19-infection-and-illness-in-healthy-young-adult-volunteers. opens in new tab).

5. Bradburne AF, Bynoe ML, Tyrrell DAJ. Effects of a “new” human respiratory virus in volunteers. Br Med J 1967;3:767-769.

服务条款 | 隐私政策 | 联系我们