University of Siena, Institute for Global Health, Santa Chiara Lab, Via Val di Montone, 1, 53100 Siena, SI, Italy.
Bill and Melinda Gates Medical Research Institute (Gates MRI), Cambridge, MA, United States.
Vaccine. 2022 Feb 23;40(9):1261-1270. doi: 10.1016/j.vaccine.2022.01.037. Epub 2022 Jan 31.
Owing to the globalization of vaccine clinical trials, as well as advances in technologies, improved research accountability, and robust regulatory and ethical scrutiny, the choice to perform human challenge trials has become evident, and one of the most significant applications of human challenge trials is the assessment of vaccine efficacy. While human challenge trials have largely been conducted in high-income countries, the concept is relatively new in many low- and middle-income countries. Thus, the aim of this study was to identify the critical success factors for conducting human challenge trials for vaccine development in low- and middle-income countries.
Using a two-step methodology, we first carried out a systematic literature review that was centered on identifying low- and middle-income countries that are either establishing a framework for, have conducted, or are conducting human challenge trials for vaccine development; secondly, we conducted a descriptive cross-sectional survey using a standardized semi-structured online questionnaire administered to eligible stakeholders, to identify the critical success factors for conducting human challenge trials for vaccine development in low- and middle-income countries. Seventeen low- and middle-income countries were identified and included in the survey.
The most cited critical success factors for conducting human challenge trials for vaccine development in low- and middle-income countries were Informed Consent, Risk Compensation and/or Reimbursement, Participant Safety and/or Public Protection, Community Engagement, Infrastructural Capacity, and Ethical and Regulatory Frameworks.
From an empirical perspective, this study provides a list of critical success factors that form the basic structure to guide the design and implementation of further human challenge trials in low- and middle-income countries. Further studies are needed to establish a standardized conceptual framework to aid in the review, approval and overall conduct of human challenge trials in low- and middle-income countries.
由于疫苗临床试验的全球化以及技术的进步、研究问责制的改善、强大的监管和伦理审查，进行人体挑战试验的选择变得显而易见，而人体挑战试验最重要的应用之一是评估疫苗的有效性。虽然人体挑战试验主要在高收入国家进行，但在许多低收入和中等收入国家，这一概念相对较新。因此，本研究的目的是确定在低收入和中等收入国家进行疫苗开发人体挑战试验的关键成功因素。
使用两步法，我们首先进行了系统的文献回顾，重点是确定正在建立或已经进行或正在进行疫苗开发人体挑战试验的框架的低收入和中等收入国家；其次，我们使用标准化的半结构化在线问卷对合格利益相关者进行了描述性横断面调查，以确定在低收入和中等收入国家进行疫苗开发人体挑战试验的关键成功因素。确定了 17 个低收入和中等收入国家并将其纳入调查。
在低收入和中等收入国家进行疫苗开发人体挑战试验的最常被引用的关键成功因素是知情同意、风险补偿和/或报销、参与者安全和/或公共保护、社区参与、基础设施能力以及伦理和监管框架。
从实证的角度来看，本研究提供了一系列关键成功因素，构成了指导在低收入和中等收入国家进一步进行人体挑战试验的设计和实施的基本结构。需要进一步的研究来建立一个标准化的概念框架，以帮助审查、批准和整体开展低收入和中等收入国家的人体挑战试验。
