Novavax Initiates First Phase 1 Clinical Trial of Its A(H7N9) Influenza Vaccine Candidate

barbara.lempert

ROCKVILLE, Md., July 8, 2013 (GLOBE NEWSWIRE) — , Inc. (Nasdaq:NVAX) today announced that enrollment has begun in a 1 of its monovalent virus-like particle (VLP) for the prevention of disease due to A/Anhui/1/13-like A(H7N9) avian viruses (A(H7N9) ).

This Phase 1, randomized, observer-blinded, placebo-controlled trial will enroll up to 280 eligible adults. Each subject will be randomized into one of seven treatment groups, including placebo, or varying doses of the A(H7N9) vaccine, with or without an adjuvant. Each subject will receive two identical intramuscular doses at Day 0 and Day 21 and undergo study follow-up for approximately one year after the second dose. All subjects will be evaluated for safety and immunogenicity.

“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,” said Stan Erck, President and Chief Executive Officer of Novavax. “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.”

About A(H7N9) Influenza

In March 2013, avian-origin A(H7N9) viruses emerged as human pathogens in Southeastern China. As of 4 July 2013, 133 human cases had been reported to the WHO from China, including 43 deaths. The majority of these patients were hospitalized with severe pneumonia, acute respiratory distress syndrome and multi-organ dysfunction. Immunologic experience with these A(H7N9) viruses had not been observed previously in the general population. In the event these viruses gain the ability for efficient and sustained human-to-human…Read more

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