Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines
Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines
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DOI：
10.1016/j.vaccine.2020.05.064
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发表时间：
2020-06-26
期刊：
影响因子：
5.5
通讯作者：
Cramer, Jakob P.
中科院分区：
文献类型：
--
作者：
Lambert, Paul-Henri;Ambrosino, Donna M.;Cramer, Jakob P.
一种新型冠状病毒（CoV），即严重急性呼吸综合征冠状病毒2（SARS-CoV-2），于2019年底在中国武汉出现，并已成为全球大流行病。因此，迫切需要安全有效的疫苗，以降低2019冠状病毒病（COVID-19）疾病的显著发病率和死亡率，并减轻重大经济影响。疫苗开发人员做出了前所未有的快速反应，目前有100多个候选疫苗正在开发中，至少有6个已经进入临床试验。然而，快速开发过程中的一个主要挑战是通过深思熟虑的疫苗设计和及时的全面评估来避免安全问题。过去曾报道过一些病毒疫苗的“疾病增强”综合征，其中免疫者在后来遇到病毒时遭受严重程度增加或死亡，或发现感染频率增加。动物模型使科学家能够确定前者在呼吸道合胞病毒（RSV）疫苗情况下的潜在机制，并已用于设计和筛选新的RSV候选疫苗。由于一些中东呼吸综合征（MERS）和SARS-CoV-1疫苗在一些动物模型中显示出疾病增强的证据，这是SARS-CoV-2疫苗特别值得关注的问题。为了应对这一挑战，流行病防范创新联盟（CEPI）和布莱顿合作（BC）紧急疫苗安全平台（SPEAC）于3月12日和13日召开了一次科学工作会议，2020年，疫苗免疫学和冠状病毒领域的专家将考虑哪些疫苗设计可以减少安全性问题，以及如何在早期临床试验中进行动物模型和免疫学评估可以帮助评估风险。本报告总结了所提供的证据，并为加速疫苗开发中COVID-19候选疫苗的安全性评估提供了考虑因素。
A novel coronavirus (CoV), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in late 2019 in Wuhan, China and has since spread as a global pandemic. Safe and effective vaccines are thus urgently needed to reduce the significant morbidity and mortality of Coronavirus Disease 2019 (COVID-19) disease and ease the major economic impact. There has been an unprecedented rapid response by vaccine developers with now over one hundred vaccine candidates in development and at least six having reached clinical trials. However, a major challenge during rapid development is to avoid safety issues both by thoughtful vaccine design and by thorough evaluation in a timely manner. A syndrome of "disease enhancement" has been reported in the past for a few viral vaccines where those immunized suffered increased severity or death when they later encountered the virus or were found to have an increased frequency of infection. Animal models allowed scientists to determine the underlying mechanism for the former in the case of Respiratory syncytial virus (RSV) vaccine and have been utilized to design and screen new RSV vaccine candidates. Because some Middle East respiratory syndrome (MERS) and SARS-CoV-1 vaccines have shown evidence of disease enhancement in some animal models, this is a particular concern for SARS-CoV-2 vaccines. To address this challenge, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration (BC) Safety Platform for Emergency vACcines (SPEAC) convened a scientific working meeting on March 12 and 13, 2020 of experts in the field of vaccine immunology and coronaviruses to consider what vaccine designs could reduce safety concerns and how animal models and immunological assessments in early clinical trials can help to assess the risk. This report summarizes the evidence presented and provides considerations for safety assessment of COVID-19 vaccine candidates in accelerated vaccine development.