Journal article
Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant
DL Gordon, D Sajkov, Y Honda-Okubo, SH Wilks, M Aban, IG Barr, N Petrovsky
Vaccine | ELSEVIER SCI LTD | Published : 2016
Abstract
Influenza vaccines are usually non-adjuvanted but addition of adjuvant may improve immunogenicity and permit dose-sparing, critical for vaccine supply in the event of an influenza pandemic. The aim of this first-in-man study was to determine the effect of delta inulin adjuvant on the safety and immunogenicity of a reduced dose seasonal influenza vaccine. Healthy male and female adults aged 18–65 years were recruited to participate in a randomized controlled study to compare the safety, tolerability and immunogenicity of a reduced-dose 2007 Southern Hemisphere trivalent inactivated influenza vaccine formulated with Advax™ delta inulin adjuvant (LTIV + Adj) when compared to a full-dose of the ..
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Awarded by National Institutes of Health
Funding Acknowledgements
Development of Advax adjuvant was supported by Contracts U01-AI061142 and HHSN272200800039C from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, United States. This publication's contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. We thank the clinical trial coordinators and research staff including Sharen Pringle and Kylie Bragg for their expert assistance. We thank Dr. Sue Heinzel for her contribution to study planning and implementation. We thank all the study subjects for their participation. We thank WHO Collaborating Centre for Reference and Research on Influenza Melbourne for supplying influenza typing kits.