Meeting report: Convening on the influenza human viral challenge model for universal influenza vaccines, Part 1: Value; challenge virus selection; regulatory, industry and ethical considerations; increasing standardization, access and capacity

Vaccine
Bruce L InnisJoseph S Bresee

Abstract

In response to global interest in the development of a universal influenza vaccine, the Bill & Melinda Gates Foundation, PATH, and the Global Funders Consortium for Universal Influenza Vaccine Development convened a meeting of experts (London, UK, May 2018) to assess the role of a standardized controlled human influenza virus infection model (CHIVIM) towards the development of novel influenza vaccine candidates. This report (in two parts) summarizes those discussions and offers consensus recommendations. This article (Part 1) covers challenge virus selection, regulatory and ethical considerations, and issues concerning standardization, access, and capacity. Part 2 covers specific methodologic considerations. Current methods for influenza vaccine development and licensure require large costly field trials. The CHIVIM requires fewer subjects and the controlled setting allows for better understanding of influenza transmission and host immunogenicity. The CHIVIM can be used to identify immune predictors of disease for at-risk populations and to measure efficacy of potential vaccines for further development. Limitations to the CHIVIM include lack of standardization, limited access to challenge viruses and assays, lack of consensus r...Continue Reading

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Citations

Oct 28, 2019·Tropical Medicine & International Health : TM & IH·W G MetzgerB G Mordmüller
Dec 15, 2019·Influenza and Other Respiratory Viruses·Florian KrammerRebecca Jane Cox
Jun 5, 2020·The Journal of Infectious Diseases·Liza DawsonJeffrey Livezey
Oct 20, 2020·Evolution, Medicine, and Public Health·Maciej Henneberg, Frank Rühli
Aug 7, 2021·Vaccines·Ericka Kirkpatrick Roubidoux, Stacey Schultz-Cherry

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Clinical Trials Mentioned

NCT02918006

Software Mentioned

ISARIC
CHIVIM
TIPRA

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