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Exploring Risks of Human Challenge Trials For COVID-19.探索 COVID-19 人体挑战试验的风险。
Risk Anal. 2021 May;41(5):710-720. doi: 10.1111/risa.13726. Epub 2021 May 4.
2
How to Test Severe Acute Respiratory Syndrome Coronavirus 2 Vaccines Ethically Even After One Is Available.如何在有疫苗可用的情况下,仍以合乎道德的方式测试严重急性呼吸综合征冠状病毒 2 型疫苗。
Clin Infect Dis. 2021 Dec 16;73(12):2332-2334. doi: 10.1093/cid/ciab182.
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Prioritizing second-generation SARS-CoV-2 vaccines through low-dosage challenge studies.通过低剂量挑战研究优先考虑第二代 SARS-CoV-2 疫苗。
Int J Infect Dis. 2021 Apr;105:307-311. doi: 10.1016/j.ijid.2021.02.038. Epub 2021 Feb 13.
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Model-informed COVID-19 vaccine prioritization strategies by age and serostatus.基于模型的 COVID-19 疫苗优先接种策略,按年龄和血清学状态分层。
Science. 2021 Feb 26;371(6532):916-921. doi: 10.1126/science.abe6959. Epub 2021 Jan 21.
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Testing SARS-CoV-2 vaccine efficacy through deliberate natural viral exposure.通过故意自然病毒暴露来测试 SARS-CoV-2 疫苗的功效。
Clin Microbiol Infect. 2021 Mar;27(3):372-377. doi: 10.1016/j.cmi.2020.12.032. Epub 2021 Jan 6.
6
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.
7
Broad cross-national public support for accelerated COVID-19 vaccine trial designs.广泛的跨国公众支持加速 COVID-19 疫苗试验设计。
Vaccine. 2021 Jan 8;39(2):309-316. doi: 10.1016/j.vaccine.2020.11.072. Epub 2020 Dec 14.
8
COVID-19 vaccine trial ethics once we have efficacious vaccines.一旦我们有了有效的新冠疫苗,新冠疫苗试验伦理。
Science. 2020 Dec 11;370(6522):1277-1279. doi: 10.1126/science.abf5084. Epub 2020 Dec 3.
9
Opinion: For now, it's unethical to use human challenge studies for SARS-CoV-2 vaccine development.观点:目前,将人体挑战试验用于新冠病毒疫苗研发是不道德的。
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10
Immunological considerations for SARS-CoV-2 human challenge studies.SARS-CoV-2 人体挑战研究的免疫学考虑因素。
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新冠病毒疫苗挑战试验是否存在独特的可推广性问题?

Do coronavirus vaccine challenge trials have a distinctive generalisability problem?

机构信息

Center for Population-Level Bioethics, Department of Philosophy (SAS) and Department of HBSP (SPH), Rutgers University, New Brunswick, New Jersey, USA

Center for Pharmacoepidemiology and Treatment Science and Ernest Mario School of Pharmacy, Rutgers University, New Brunswick, New Jersey, USA.

出版信息

J Med Ethics. 2022 Sep;48(9):586-589. doi: 10.1136/medethics-2020-107109. Epub 2021 Jun 7.

DOI:10.1136/medethics-2020-107109
PMID:34099541
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10013549/
Abstract

Notwithstanding the success of conventional field trials for vaccines against COVID-19, human challenge trials (HCTs) that could obtain more information about these and about other vaccines and further strategies against it are about to start in the UK. One critique of COVID-19 HCTs is their distinct paucity of information on crucial population groups. For safety reasons, these HCTs will exclude candidate participants of advanced age or with comorbidities that worsen COVID-19, yet a vaccine should (perhaps especially) protect such populations. We turn this cliché on its head. The truth is that either an HCT or a field trial has intrinsic generalisability limitations, that an HCT can expedite protection of high-risk participants even without challenging them with the virus, and that an important route to obtaining results generalisable to high-risk groups under either strategy is facilitated by HCTs.

摘要

尽管针对 COVID-19 的常规疫苗现场试验取得了成功,但人类挑战试验(HCT)即将在英国开始,这将为了解这些疫苗以及其他疫苗和针对该病毒的进一步策略提供更多信息。对 COVID-19 HCT 的一个批评是,它们在关键人群组方面的信息明显不足。出于安全原因,这些 HCT 将排除年龄较大或患有使 COVID-19 恶化的合并症的候选参与者,但疫苗应该(尤其是)保护这些人群。我们将这句话反过来。事实是,HCT 或现场试验都具有内在的普遍性限制,HCT 可以在不使高危参与者感染病毒的情况下加快对他们的保护,并且在这两种策略下获得可推广至高危人群的结果的重要途径是通过 HCT 实现的。