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Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens 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.

Abstract

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.

Item Metadata

Title
Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
Creator
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.
Contributor
St. Paul's Hospital (Vancouver, B.C.)
Publisher
Multidisciplinary Digital Publishing Institute
Date Issued
2024-12-29
Description
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.
Subject
immunobridging; clinical trials; immunocompromise; vaccines; monoclonal antibodies
Genre
Article
Type
Text
Language
eng
Date Available
2025-02-03
Provider
Vancouver : University of British Columbia Library
Rights
CC BY 4.0
DOI
10.14288/1.0447907
URI
http://hdl.handle.net/2429/90312
Affiliation
Medicine, Faculty of; Non UBC
Citation
Vaccines 13 (1): 19 (2025)
Publisher DOI
10.3390/vaccines13010019
Peer Review Status
Reviewed
Scholarly Level
Faculty; Researcher
Rights URI
https://creativecommons.org/licenses/by/4.0/
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CC BY 4.0