NOVAVAX Launches Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate

Novavax, Inc.

announced today that it has begun enrollment in a Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent a potential pandemic disease due to A/H5N1 avian influenza viruses. This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of the trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine's immunogenicity with and without the use of an undisclosed adjuvant . The Phase I trial will enroll healthy adult subjects, each of whom 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 is being conducted in a stepwise manner, enrolling increasing number of subjects, until a target of approximately 333 subjects is reached. All subjects will be evaluated for safety and immunogenicity. Trial participants will receive two identical intramuscular injections at a 21-day interval (Day 0 and Day 21) with study follow-up approximately 13 months from the first dose.