System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Publications

Journal Article Epublish 1 citation

PubMed: 39852798 DOI: 10.3390/vaccines13010019

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

Vaccines (Basel) 13(1)

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

Affiliations

  • 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.
  • University College London, London WC1E 6BT, UK.
  • Al Rahba Hospital, HMCV+XHF, AL Shahama, United Arab Emirates.
  • Division of Population Health and Genomics, University of Dundee, Dundee DD1 4HN, UK.
  • University of Oxford, Oxford OX1 2JD, UK.
  • Infectious Diseases Unit, Samson Assuta Ashdod University Hospital, Ashdod 7747629, Israel.
  • Faculty of Health Sciences, Ben Gurion University in the Negev, Beer Sheba 8410501, Israel.
  • Division of Nephrology, St. Paul's Hospital, The University of British Columbia, Vancouver, BC V6Z 1Y6, Canada.
  • University of Pittsburgh, Pittsburgh, PA 15260, USA.
  • Tulane University, New Orleans, LA 70118, USA.
  • Infectious Disease Unit, Edith Wolfson Medical Center, Holon 5822012, Israel.
  • Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.
  • Kings College London, London WC2R 2LS, UK.
  • CHU Nantes, INSERM, Department of Infectious Diseases, Nantes Université, CIC 1413, 44093 Nantes, France.
  • NYU Grossman School of Medicine, New York, NY 10016, USA.
  • Centre for Immuno-Oncology, University of Oxford, Oxford OX3 7DQ, UK.

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.

MeSH

Vaccines, Pharmaceutical Preparations, Antibodies, Monoclonal, Immunocompromised Host, Communicable Diseases