Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial
Angus H Forster, Katey Witham, Alexandra CI Depelsenaire, Margaret Veitch, James W Wells, Adam Wheatley, Melinda Pryor, Jason D Lickliter, Barbara Francis, Steve Rockman, Jesse Bodle, Peter Treasure, Julian Hickling, Germain JP Fernando
PLOS MEDICINE | PUBLIC LIBRARY SCIENCE | Published : 2020
BACKGROUND: The Vaxxas high-density microarray patch (HD-MAP) consists of a high density of microprojections coated with vaccine for delivery into the skin. Microarray patches (MAPs) offer the possibility of improved vaccine thermostability as well as the potential to be safer, more acceptable, easier to use, and more cost-effective for the administration of vaccines than injection by needle and syringe (N&S). Here, we report a phase I trial using the Vaxxas HD-MAP to deliver a monovalent influenza vaccine that was to the best of our knowledge the first clinical trial to evaluate the safety, tolerability, and immunogenicity of lower doses of influenza vaccine delivered by MAPs. METHODS AND F..View full abstract
The study was entirely funded by Vaxxas Pty Ltd, Brisbane QLD 4102 Australia.