Convening on the influenza human viral challenge model for universal influenza vaccines, Part 2: Methodologic considerations

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. Part 1 covers challenge virus selection, regulatory and ethical considerations, and issues concerning standardization, access, and capacity. This article (Part 2) summarizes the discussion and recommendations concerning CHIVIM methods. The panelists identified an overall need for increased standardization of CHIVIM trials, in order to produce comparable results that can support universal vaccine licensure. Areas of discussion included study participant selection and screening, route of exposure and dose, devices for administering challenge, rescue therapy, protection of participants and institutions, clinical outcome measures, and other considerations. The panelists agreed upon specific recommendations to improve the standardiz...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
Jul 7, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Linh Chi NguyenJosh Morrison
Oct 23, 2020·Nature Reviews. Immunology·Alexander D Douglas, Adrian V S Hill

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