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 Raffi,
Ffion Samuels,
Dorry Segev,
Yuxin Ying,
Lennard Y. W. Lee
Affiliations
Pedro Cruz
Department of Medical Oncology, Portuguese Oncology Institute of Porto (IPO-Porto)/Porto Comprehensive Cancer Center Raquel Seruca (Porto. CCC Raquel Seruca), 4200-072 Porto, Portugal
Jie Min Lam
University College London, London WC1E 6BT, UK
Jehad Abdalla
Al Rahba Hospital, HMCV+XHF, AL Shahama, United Arab Emirates
Samira Bell
Division of Population Health and Genomics, University of Dundee, Dundee DD1 4HN, UK
Jola Bytyci
University of Oxford, Oxford OX1 2JD, UK
Tal Brosh-Nissimov
Infectious Diseases Unit, Samson Assuta Ashdod University Hospital, Ashdod 7747629, Israel
John Gill
Division of Nephrology, St. Paul’s Hospital, The University of British Columbia, Vancouver, BC V6Z 1Y6, Canada
Ghady Haidar
University of Pittsburgh, Pittsburgh, PA 15260, USA
Michael Hoerger
Tulane University, New Orleans, LA 70118, USA
Yasmin Maor
Infectious Disease Unit, Edith Wolfson Medical Center, Holon 5822012, Israel
Antonio Pagliuca
Kings College London, London WC2R 2LS, UK
Francois Raffi
CHU Nantes, INSERM, Department of Infectious Diseases, Nantes Université, CIC 1413, 44093 Nantes, France
Ffion Samuels
University of Oxford, Oxford OX1 2JD, UK
Dorry Segev
NYU Grossman School of Medicine, New York, NY 10016, USA
Yuxin Ying
University of Oxford, Oxford OX1 2JD, UK
Lennard Y. W. Lee
Centre for Immuno-Oncology, University of Oxford, Oxford OX3 7DQ, UK
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.
