TY - JOUR
T1 - Immunobridging Trials
T2 - An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
AU - on behalf of the Global Immunocompromised Health Coalition
AU - Cruz, Pedro
AU - Lam, Jie Min
AU - Abdalla, Jehad
AU - Bell, Samira
AU - Bytyci, Jola
AU - Brosh-Nissimov, Tal
AU - Gill, John
AU - Haidar, Ghady
AU - Hoerger, Michael
AU - Maor, Yasmin
AU - Pagliuca, Antonio
AU - Raffi, Francois
AU - Samuels, Ffion
AU - Segev, Dorry
AU - Ying, Yuxin
AU - Lee, Lennard Y.W.
N1 - Publisher Copyright:
© 2024 by the authors.
PY - 2025/1/1
Y1 - 2025/1/1
N2 - 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.
AB - 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.
KW - clinical trials
KW - immunobridging
KW - immunocompromise
KW - monoclonal antibodies
KW - vaccines
UR - http://www.scopus.com/inward/record.url?scp=85216186490&partnerID=8YFLogxK
U2 - 10.3390/vaccines13010019
DO - 10.3390/vaccines13010019
M3 - Article
C2 - 39852798
AN - SCOPUS:85216186490
SN - 2076-393X
VL - 13
JO - Vaccines
JF - Vaccines
IS - 1
M1 - 19
ER -