An Avian influenza vaccine by Novavax has achieved its primary endpoints in two Phase I clinical trials, supporting further development of the vaccine.
The primary endpoint of the Phase I study was to prove safety and immunogenicity of varying dose levels of the vaccine, with or without adjuvant, and the demonstration of statistically significant adjuvant effects on the immune responses.
Both objectives were achieved and the vaccine’s safety was also considered acceptable. No vaccine-related serious adverse effects were noted.
The avian influenza vaccine, also known as bird flu vaccine, was administered alone or with one of two undisclosed adjuvants in two randomised, observer-blind, dose-ranging, placebo-controlled Phase I trials.
Novavax president and CEO, Stanley Erck, said; "The data from these trials represent a landmark event in the history of Novavax. We have demonstrated that Novavax can produce antigens from avian influenza strains that are as, or more, immunogenic than any other described in published results to date.
"Importantly, as we accelerate our development activities, these results give us tremendous flexibility for pursuing pandemic vaccine products, including vaccines directed at population segments that are sensitive to adjuvant use."
666 participants in the trial aged 18 – 49 were given an intramuscular injection of vaccine or placebo at day 0 and day 21, and will be followed for 13 months following the first dose. The current data relates to safety and immune responses over the first 42 days.
The current data would fulfil immunogenicity criteria set forth by the European Medicines Agency and would also fulfil US Food and Drug Administration Center for Biologics Evaluation and Research seroprotection and seroconversion criteria for accelerated approval at the lower bound of the 95% confidence level.