Immunobridging trials: an important tool to protect vulnerable and immunocompromised patients against evolving pathogens

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  Raff; Ffion  Samuels; Dorry  Segev; Yuxin  Ying; Lennard Y W Lee

doi:10.3390/vaccines13010019

Immunobridging trials: an important tool to protect vulnerable and immunocompromised patients against evolving pathogens

, 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 Raff, Ffion Samuels, Dorry Segev, Yuxin Ying, Lennard Y W Lee (Lead / Corresponding author)

Population Health and Genomics

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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.

Original language	English
Article number	19
Number of pages	10
Journal	Vaccines
Volume	13
Issue number	1
DOIs	https://doi.org/10.3390/vaccines13010019
Publication status	Published - 29 Dec 2024

Keywords

immunobridging
clinical trials
immunocompromise
vaccines
monoclonal antibodies

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.3390/vaccines13010019Licence: CC BY

Final Published VersionFinal published version, 578 KBLicence: CC BY

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, Cruz, P., Lam, J. M., Abdalla, J., Bell, S., Bytyci, J., Brosh-Nissimov, T., Gill, J., Haidar, G., Hoerger, M., Maor, Y., Pagliuca, A., Raff, F., Samuels, F., Segev, D., & Ying, Y., & Lee, L. Y. W. (2024). Immunobridging trials: an important tool to protect vulnerable and immunocompromised patients against evolving pathogens. Vaccines, 13(1), Article 19. https://doi.org/10.3390/vaccines13010019

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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.",

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Cruz, P, Lam, JM, Abdalla, J, Bell, S, Bytyci, J, Brosh-Nissimov, T, Gill, J, Haidar, G, Hoerger, M, Maor, Y, Pagliuca, A, Raff, F, Samuels, F, Segev, D & Ying, Y & Lee, LYW 2024, 'Immunobridging trials: an important tool to protect vulnerable and immunocompromised patients against evolving pathogens', Vaccines, vol. 13, no. 1, 19. https://doi.org/10.3390/vaccines13010019

TY - JOUR

T1 - Immunobridging trials

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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 - Raff, Francois

AU - Samuels, Ffion

AU - Segev, Dorry

AU - Ying, Yuxin

AU - Lee, Lennard Y W

PY - 2024/12/29

Y1 - 2024/12/29

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 - immunobridging

KW - clinical trials

KW - immunocompromise

KW - vaccines

KW - monoclonal antibodies

U2 - 10.3390/vaccines13010019

DO - 10.3390/vaccines13010019

M3 - Article

SN - 2076-393X

VL - 13

JO - Vaccines

JF - Vaccines

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M1 - 19

ER -

Immunobridging trials: an important tool to protect vulnerable and immunocompromised patients against evolving pathogens

Abstract

Keywords

UN SDGs

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