Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure
Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure
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DOI：
10.1093/infdis/jiaa152
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发表时间：
2020-06-01
影响因子：
6.4
通讯作者：
Smith, Peter G.
中科院分区：
文献类型：
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作者：
Eyal, Nir;Lipsitch, Marc;Smith, Peter G.
SARS-CoV-2 候选疫苗的受控人体挑战试验可以加速有效疫苗的测试和潜在推广。通过取代候选疫苗的传统三期测试，此类试验可能会缩短许可过程的数月时间，从而更快地提供有效的疫苗。显然，用这种活病毒挑战志愿者可能会引发严重疾病，甚至可能死亡。然而，我们认为，此类研究通过加速疫苗评估，可以减轻与冠状病毒相关的死亡率和发病率的全球负担。此类研究中的志愿者可以自主授权自己承担风险，如果参与者包括健康的年轻人，他们在自然感染后患严重疾病的风险相对较低，如果他们有较高的自然感染基线风险，如果在试验期间他们接受频繁的监测，并且在任何感染后接受最好的护理，那么他们的净风险是可以接受的。
Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care.