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. 2024 Dec 29;13(1):19.
doi: 10.3390/vaccines13010019.

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

Pedro Cruz  1 , Jie Min Lam  2 , Jehad Abdalla  3 , Samira Bell  4 , Jola Bytyci  5 , Tal Brosh-Nissimov  6   7 , John Gill  8 , Ghady Haidar  9 , Michael Hoerger  10 , Yasmin Maor  11   12 , Antonio Pagliuca  13 , Francois Raffi  14 , Ffion Samuels  5 , Dorry Segev  15 , Yuxin Ying  5 , Lennard Y W Lee  16 ; Global Immunocompromised Health Coalition
Affiliations

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

Pedro Cruz et al. Vaccines (Basel). .

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.

Keywords: clinical trials; immunobridging; immunocompromise; monoclonal antibodies; vaccines.

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Conflict of interest statement

PC has received honorarium from AstraZeneca. SB has received fees for advisory work from AstraZeneca, GSK, Bayer. TB has received honorarium from MSD, AstraZeneca, Gilead, GSK, Medison. GH is a recipient of research grants from Allovir, Karius, Regeneron, the Cystic Fibrosis Foundation, and AstraZeneca. GH also serves on the scientific advisory boards of Karius, AstraZeneca, and SNIPR BIOME and has received honoraria from MDOutlook, PeerView Institute for Medical Education, and PRIME Inc. YM has received honorarium from Pfizer, AstraZeneca, MSD, Medison, GSK, and Gilead. AP has received advisory board fees from AstraZeneca. FR has received honorarium from AstraZeneca, GSK and Roche. DS has received honoraria from Sanofi, AstraZeneca, and Caredx. LL has received honorarium from Pfizer, AstraZeneca.

Figures

Figure 1
Figure 1
Immunobridging paradigm.
Figure 2
Figure 2
Phase 3b immunobridging trials accelerate drug update and approval, thus decreasing the timespan in which patients are unprotected against new variants.
See this image and copyright information in PMC

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