Cruz Pedro, Lam Jie Min, Abdalla Jehad, Bell Samira, Bytyci Jola, Brosh-Nissimov Tal, Gill John, Haidar Ghady, Hoerger Michael, Maor Yasmin, Pagliuca Antonio, Raffi Francois, Samuels Ffion, Segev Dorry, Ying Yuxin, Lee Lennard Y W
Department of Medical Oncology, Portuguese Oncology Institute of Porto (IPO-Porto)/Porto Comprehensive Cancer Center Raquel Seruca (Porto. CCC Raquel Seruca), 4200-072 Porto, Portugal.
University College London, London WC1E 6BT, UK.
Vaccines (Basel). 2024 Dec 29;13(1):19. doi: 10.3390/vaccines13010019.
Safeguarding patients from emerging infectious diseases demands strategies that prioritise patient well-being and protection. Immunobridging is an established trial methodology which has been increasingly employed to ensure patient protection and provide clinicians with swift access to vaccines. It uses immunological markers to infer the effectiveness of a new drug through a surrogate measure of efficacy. Recently, this method has also been employed to authorise novel drugs, such as COVID-19 vaccines, and this article explores the concepts behind immunobridging trials, their advantages, issues, and significance in the context of COVID-19 and other infectious diseases. Our goal is to improve awareness among clinicians, patient groups, regulators, and health leaders of the opportunities and issues of immunobridging, so that fewer patients are left without protection from infectious diseases, particularly from major pathogens that may emerge.
保护患者免受新出现的传染病侵害需要优先考虑患者福祉和保护的策略。免疫桥接是一种既定的试验方法,越来越多地用于确保患者得到保护,并为临床医生提供快速获取疫苗的途径。它利用免疫标志物通过疗效的替代指标来推断新药的有效性。最近,这种方法也被用于批准新型药物,如新冠疫苗,本文探讨了免疫桥接试验背后的概念、其优势、问题以及在新冠疫情和其他传染病背景下的意义。我们的目标是提高临床医生、患者群体、监管机构和卫生领域领导者对免疫桥接的机遇和问题的认识,从而使更少的患者得不到传染病的防护,尤其是可能出现的主要病原体的防护。