Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults

Summary

A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 18-49 years of age. A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).

Timeline

Start

2013-10-08

Primary completion

2014-06-30

Completion

2014-06-30

Publications

• Results Pillet S, Aubin E, Trepanier S, Bussiere D, Dargis M, Poulin JF, Yassine-Diab B, Ward BJ, Landry N. A plant-derived quadrivalent virus like particle influenza vaccine induces cross-reactive antibody and T cell response in healthy adults. Clin Immunol. 2016 Jul;168:72-87. doi: 10.1016/j.clim.2016.03.008. Epub 2016 Mar 14.

Drugs

Indications