Novavax initiates Phase I trial of H7N9 influenza vaccine candidate

Novavax, Inc., a Rockville, Maryland-based clinical-stage biopharmaceutical company, announced on Monday that enrollment began in a Phase I clinical trial of the company's vaccine candidate against influenza A H7N9.

The placebo-controlled, observer-blinded, randomized, Phase I trial of Novavax's monovalent virus-like particle vaccine candidate will enroll as many as 280 eligible adults. Each subject in the trial will be randomized into one of seven treatment groups. There will be one placebo group and groups with varying doses of the vaccine candidate, with or without an adjuvant.

Each subject will receive two intramuscular doses on the first day and day 21. There will be study follow-up for approximately one year following the second dose. All subjects will be evaluated for immunogenicity and safety.

"Novavax has moved our program rapidly from the A/Anhui/1/13-like (H7N9) viral gene sequence, to vaccine candidate, into multiple animal studies, and now, exactly three months after the gene sequence was obtained, into a clinical trial," Stan Erck, the president and CEO of Novavax, said. "We expect to report top-line results from this clinical trial later this year. This level of performance is a testament to the Novavax technology and the hard-work and commitment of its people. It serves as a powerful example of the company's ability to respond rapidly to any future pandemic event."

As of Thursday, China reported 133 human cases of H7N9 influenza to the World Health Organization, including 43 deaths. While the first epidemic appears to have subsided, the potential for a second wave suggests an urgent need for H7N9 influenza vaccine development.

Novavax develops VLP-based vaccines, which are produced more rapidly than egg-based vaccine because of the combination between the company's cell-culture technology platform and single-use bioprocessing technology.