Enrolment for the Phase 1 clinical trial of Novavax‘s vaccine candidate for the prevention of disease due to A(H7N9) avian influenza viruses has commenced, the biopharmaceutical company announced yesterday.
Avian-origin A (H7N9) viruses emerged as human pathogens in southeastern China in March 2013. As of 4 July 2013, 133 human cases have been reported to the World Health Organisation from China, including 43 deaths.
President and chief executive officer of Novavax, Stan Erck, said, "Novavax has moved our programme 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."
Novavax’s vaccine is a monovalent virus-like particle (VLP) vaccine candidate, which uses structures resembling the external structure of viruses.
When used as an antigen in a vaccine, it elicits broad and strong antibody and cellular immune responses, but lacks the live genetic material that causes viral replication and infection.
VLPs can be designed quickly to match novel viral strains and be produced efficiently using portable recombinant cell-culture technology.
The majority of the patients with A(H7N9) avian influenza were hospitalised with severe pneumonia, acute respiratory distress syndrome and multi-organ dysfunction.
Although the epidemic is considered to have largely subsided, the presence of a natural reservoir, the lack of antibodies to A(H7N9) in the general population, the severity of the disease and the potential for a second-wave epidemic altogether suggest an urgent need for A(H7N9) vaccine development.
"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," Erck stated.
The trial is a randomised, observer-blinded, placebo-controlled trial that aims to recruit 280 eligible adults. Each participant will be put in one of seven treatment groups, from placebo to varying doses of the A(H7N9) vaccine.
Each patient 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.
