Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials.
Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials.
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DOI：
10.3390/vaccines8040746
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发表时间：
2020-12-09
期刊：
影响因子：
7.8
通讯作者：
Memoli MJ
中科院分区：
文献类型：
--
作者：
Giurgea LT;Memoli MJ
针对冠状病毒病的疫苗已经以前所未有的速度开发出来，其中许多使用了新的策略。截至2020年11月，一系列出版物概述了计划进入第三阶段试验的九种不同疫苗的第一/第二阶段研究结果。结果令人鼓舞，表明严重或严重的不良事件很少发生，抗体效价的诱导也很强劲。确定具有最高保护效力和最佳不良事件概况的候选疫苗将是完善公共卫生战略的关键。然而，研究设计和数据报告方面的差异使现有的1/2期研究难以比较。在安全性方面，研究有不同的随访时间，并可能对不良事件使用不同的定义。免疫原性结果甚至更不一致，时间点的变化，所研究的抗体类型的关键差异，以及检测方法的差异。此外，新冠肺炎中的保护相关因素尚不清楚。协调3期试验设计和使用客观和有意义的临床结果将对简化未来全球对大流行的反应至关重要。
Vaccines against Coronavirus Disease 2019 Originated-19) have been developed with unprecedented rapidity, many utilizing novel strategies. As of November 2020, a series of publications have outlined the results of phase 1/2 studies of nine different vaccines planned to move forward to phase 3 trials. The results are encouraging, demonstrating a paucity of severe or serious adverse events and robust induction of antibody titers. Determination of the vaccine candidates with the highest protective efficacy and best adverse event profiles will be essential in refining public health strategies. However, differences in study design and reporting of data make comparisons of existing phase 1/2 studies difficult. With respect to safety, studies have variable follow-up times and may use different definitions for adverse events. Immunogenicity outcomes are even more inconsistent, with variations in timepoints and critical differences in the types of antibodies studied as well as methodological differences in assays. Furthermore, the correlates of protection in COVID-19 are not known. Harmonization of phase 3 trial designs and use of objective and meaningful clinical outcomes will be crucial in streamlining future global responses to the pandemic.
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