Phase I enrollment for A/H5N1 influenza vaccine trial begins

Novavax, Inc., a Rockville, Maryland-based clinical-stage biopharmaceutical company, has started enrollment for its second phase I clinical trial for a monovalent virus-like particle vaccine candidate against A/H5N1 avian influenza viruses.

The placebo-controlled, dose-ranging, observer blind, randomized trial is being conducted as part of Novavax's contract with the Biomedical Advanced Research and Development Authority. BARDA is a part of the U.S. Department of Health and Human Services.

The objective of the trial is to evaluate the vaccine candidate's safety and immunogenicity with and without the use of an undisclosed adjuvant.

"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," Gregory Glenn, Novavax's senior vice president and chief medical officer, said. "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 fulfill 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."

The trial will be identical to a phase I study launched on May 1. The participants will receive two intramuscular injections at a 21 day interval and the study will conduct a follow-up approximately 13 months from the first dose. The six treatment groups will include varying doses of the vaccine candidate with or without the adjuvant or a placebo.