The manufacturing of human viral challenge agents for use in clinical studies to accelerate the drug development process

BMC Research Notes
Andrew CatchpoleRob Lambkin-Williams

Abstract

This manuscript aims to provide an overview of the unique considerations and best practice principles associated with the manufacture of human viral challenge agents. Considerations are discussed on the entire process from strain and viral source selection through manufacturing, safety and efficacy testing. The human viral challenge (HVC) model is an important tool to help accelerate the drug development process but producing viruses suitable for use in the model presents a unique set of challenges. There are many case by case decisions and risk assessments to consider and no clear international standard to produce viruses for this purpose. The authors present challenge virus manufacturing considerations from the current literature, regulatory guidance and their own direct experience in producing challenge viruses. The use of these viral stocks in clinical studies, as published in peer-reviewed journals, is also briefly described.

References

Apr 28, 2010·Proceedings of the National Academy of Sciences of the United States of America·John DeVincenzoAkshay Vaishnaw
Jul 14, 2010·American Journal of Respiratory and Critical Care Medicine·John P DeVincenzoRobert Lambkin-Williams
Feb 1, 2010·Viruses·James S Robertson, Othmar G Engelhardt
Dec 2, 2011·The Journal of Infectious Diseases·Ben KillingleyJonathan S Nguyen Van-Tam
Oct 22, 2013·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Micah T McClainChristopher W Woods
Aug 21, 2014·The New England Journal of Medicine·John P DeVincenzoJason W Chien
Jun 1, 2015·The Lancet Infectious Diseases·Thomas C DartonAndrew J Pollard
Nov 19, 2015·The New England Journal of Medicine·John P DeVincenzoJohn Fry
Apr 19, 2016·Expert Review of Respiratory Medicine·Hock TayNathan W Bartlett
Feb 28, 2017·EBioMedicine·Thomas W BurkeGeoffrey S Ginsburg

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Citations

Jul 11, 2020·Science·Seema K ShahAnnette Rid
Oct 23, 2020·Nature Reviews. Immunology·Alexander D Douglas, Adrian V S Hill
May 5, 2021·Risk Analysis : an Official Publication of the Society for Risk Analysis·David ManheimUNKNOWN 1Day Sooner Research Team

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