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

Authors :
Pedro Cruz
Jie Min Lam
Jehad Abdalla
Samira Bell
Jola Bytyci
Tal Brosh-Nissimov
John Gill
Ghady Haidar
Michael Hoerger
Yasmin Maor
Antonio Pagliuca
Francois Raffi
Ffion Samuels
Dorry Segev
Yuxin Ying
Lennard Y. W. Lee
Source :
Vaccines, Vol 13, Iss 1, p 19 (2024)
Publication Year :
2024
Publisher :
MDPI AG, 2024.

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.

Details

Language :
English
ISSN :
2076393X
Volume :
13
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Vaccines
Publication Type :
Academic Journal
Accession number :
edsdoj.675b36e693664ce4a788e9ca5dd33db4
Document Type :
article
Full Text :
https://doi.org/10.3390/vaccines13010019