Faculty of Medicine and Institute for Life Sciences, University of Southampton, School of Clinical and Experimental Sciences, NIHR Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust Mailpoint 218, University Hospital Southampton NHS Foundation Trust Tremona Road, Southampton, SO16 6YD, UK.
MRC Lifecourse Epidemiology Unit, University of Southampton, D08 Institute of Developmental Science and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospitals Southampton NHS Foundation Trust, Southampton, UK.
BMC Med. 2020 Jul 7;18(1):209. doi: 10.1186/s12916-020-01670-2.
Rapid development of an effective vaccine for SARSCoV2 is a global priority. A controlled human infection model (CHIM) would accelerate the efficacy assessment of candidate vaccines. This strategy would require deliberate exposure of volunteers to SARSCoV2 with no currently available treatment and a small but definite risk of serious illness or death. This raises complex questions about the social and ethical acceptability of risk to individuals, given the potential benefit to the wider population, and as such, a study cannot be done without public involvement. We conducted a structured public consultation with 57 individuals aged 20-40 years to understand public attitudes to a CHIM, and pre-requisites for enrolment. The overall response to this strategy was positive, and many would volunteer altruistically. Carefully controlled infection is viewed as safer than natural exposure to wild virus. The prolonged social isolation required for the proposed CHIM is considered an obstacle but not insurmountable, with reasonable compensation and supportive care. Given the significant level of public interest, a CHIM should be done as open science with regular, controlled dissemination of information into the public domain. Importantly, there was a strong view that the final decision whether to conduct a CHIM should be in the hands of qualified and experienced clinician-scientists and the authorities.
快速开发针对 SARS-CoV-2 的有效疫苗是全球重点。采用人为感染控制模型（CHIM）可加速候选疫苗的疗效评估。该策略需要将志愿者故意暴露于 SARS-CoV-2 之下，而目前尚无可用的治疗方法，存在一定的罹患重病甚至死亡的风险。考虑到对更广泛人群的潜在益处，这给个人风险的社会和伦理可接受性带来了复杂的问题，因此，如果没有公众参与，就不能进行这项研究。我们对 57 名 20-40 岁的个人进行了结构化的公众咨询，以了解公众对 CHIM 和入组条件的态度。公众对该策略的总体反应是积极的，许多人会无私地自愿参与。精心控制的感染被认为比自然接触野生病毒更安全。拟议的 CHIM 需要进行长时间的社会隔离，这被认为是一个障碍，但并非不可逾越，只要有合理的补偿和支持性护理。鉴于公众对此有浓厚的兴趣，CHIM 应该作为开放科学进行，定期、有控制地将信息传播到公共领域。重要的是，有一种强烈的观点认为，是否进行 CHIM 的最终决策应该由合格且经验丰富的临床医生和专家以及当局做出。
