Novavax, Inc., a clinical-stage biopharmaceutical company, has begun enrollment in a second phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent potential pandemic disease due to A/H5N1 avian influenza viruses (bird flu).

This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company’s contract with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of this 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 (Adjuvant 2).

This phase I trial is identical in design to the phase I study launched on May 1, 2012; it will enrol healthy 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 2, or a 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.

Gregory Glenn, M.D., Novavax’s senior vice president and chief medical officer, stated: “This second clinical trial is supporting our efforts to determine the most appropriate dose of our VLP A/H5N1 avian influenza vaccine candidate and which adjuvant, if any, will be used in our future clinical trials. Like the first A/H5N1 trial we initiated on May 1, we believe this trial will provide the data to determine whether our vaccine will fulfil the criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA’s Center for Biologics Evaluation and Research. Once again, we extend our thanks for HHS BARDA’s support for these trials and look forward to completing enrollment and presenting top-line data in the fourth quarter of this year.”