The trial is being conducted as per the contract with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (HHS BARDA).
The aim of the randomized, observer-blind, dose-ranging, placebo-controlled trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate and determine the vaccine’s immunogenicity with and without the use of an undisclosed adjuvant.
Each of the adult subjects will be randomized into one of six treatment groups including varying doses of A/H5N1 VLP vaccine, with or without Adjuvant 1, or placebo.
The trial will gradually increase its enrollment up to 333 subjects, all of whom will be evaluated for safety and immunogenicity.
Two identical intramuscular injections will be given to the participants at a 21-day interval with study follow-up about 13 months from the first dose.
Novavax senior vice president and chief medical officer Gregory Glenn said, "This is an important trial because it will help determine the most appropriate dose for future studies of our avian influenza vaccine candidate, as indicated by the safety of the vaccine, and how closely the vaccine meets the immunogenicity criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA’s Center for Biologics Evaluation and Research."