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

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...

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Main 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
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Vaccines
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Online Access:https://www.mdpi.com/2076-393X/13/1/19
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author 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
author_facet 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
author_sort Pedro Cruz
collection DOAJ
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.
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institution Kabale University
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publishDate 2024-12-01
publisher MDPI AG
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series Vaccines
spelling doaj-art-675b36e693664ce4a788e9ca5dd33db42025-01-24T13:51:41ZengMDPI AGVaccines2076-393X2024-12-011311910.3390/vaccines13010019Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving PathogensPedro Cruz0Jie Min Lam1Jehad Abdalla2Samira Bell3Jola Bytyci4Tal Brosh-Nissimov5John Gill6Ghady Haidar7Michael Hoerger8Yasmin Maor9Antonio Pagliuca10Francois Raffi11Ffion Samuels12Dorry Segev13Yuxin Ying14Lennard Y. W. Lee15Department of Medical Oncology, Portuguese Oncology Institute of Porto (IPO-Porto)/Porto Comprehensive Cancer Center Raquel Seruca (Porto. CCC Raquel Seruca), 4200-072 Porto, PortugalUniversity College London, London WC1E 6BT, UKAl Rahba Hospital, HMCV+XHF, AL Shahama, United Arab EmiratesDivision of Population Health and Genomics, University of Dundee, Dundee DD1 4HN, UKUniversity of Oxford, Oxford OX1 2JD, UKInfectious Diseases Unit, Samson Assuta Ashdod University Hospital, Ashdod 7747629, IsraelDivision of Nephrology, St. Paul’s Hospital, The University of British Columbia, Vancouver, BC V6Z 1Y6, CanadaUniversity of Pittsburgh, Pittsburgh, PA 15260, USATulane University, New Orleans, LA 70118, USAInfectious Disease Unit, Edith Wolfson Medical Center, Holon 5822012, IsraelKings College London, London WC2R 2LS, UKCHU Nantes, INSERM, Department of Infectious Diseases, Nantes Université, CIC 1413, 44093 Nantes, FranceUniversity of Oxford, Oxford OX1 2JD, UKNYU Grossman School of Medicine, New York, NY 10016, USAUniversity of Oxford, Oxford OX1 2JD, UKCentre for Immuno-Oncology, University of Oxford, Oxford OX3 7DQ, UKSafeguarding 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.https://www.mdpi.com/2076-393X/13/1/19immunobridgingclinical trialsimmunocompromisevaccinesmonoclonal antibodies
spellingShingle 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
Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
Vaccines
immunobridging
clinical trials
immunocompromise
vaccines
monoclonal antibodies
title Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
title_full Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
title_fullStr Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
title_full_unstemmed Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
title_short Immunobridging Trials: An Important Tool to Protect Vulnerable and Immunocompromised Patients Against Evolving Pathogens
title_sort immunobridging trials an important tool to protect vulnerable and immunocompromised patients against evolving pathogens
topic immunobridging
clinical trials
immunocompromise
vaccines
monoclonal antibodies
url https://www.mdpi.com/2076-393X/13/1/19
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