Novavax (Novavax) has initiated two-stage clinical study of its virus-like-particle (VLP) H1N1 influenza vaccine in Mexico in collaboration with Avimex Laboratories (Avimex) and GE Healthcare.
Avimex is providing financial support for the trial and is expected to distribute the H1N1 VLP vaccine in Mexico in 2010 if it is approved for commercial sale. Additionally, Novavax has declared that GE Healthcare has agreed to support this program by providing its single-use bioprocessing technologies for vaccine production.
Rahul Singhvi, president and CEO of Novavax, said: “Conducting this clinical trial during a pandemic, when the attack rate of the H1N1 virus is expected to be very high, provides the company with an invaluable opportunity to demonstrate field efficacy of its VLP-based H1N1 vaccine and the utility of the VLP vaccine platform for influenza as a whole.
“Our new alliance with Avimex is another example of our regional strategy and will provide valuable assistance toward the successful completion of this important clinical study within a remarkably short horizon. The fast spread of H1N1 worldwide has caused a significant strain on vaccine supply in countries with limited indigenous vaccine capabilities. We are grateful to the Mexican health authorities for their rapid clinical protocol clearance and enabling our potential solution for this escalating unmet medical need,” he added.
Catarina Flyborg, enterprise solutions leader of GE Healthcare, said: “We are delighted to support Novavax as they move into this exciting clinical trial. Alongside growing interest from organisations in India and Spain, this trial lends further credence to the combination of Novavax’s vaccine technology with GE Healthcare’s ReadyToProcess bioprocessing solutions.”
The duo are initiating the blinded, placebo-controlled clinical trial in Mexico City
to evaluate the safety, immunogenicity and efficacy of Novavax’s 2009 H1N1 VLP vaccine in healthy adults. The first stage will evaluate the vaccine’s safety, immunogenicity and efficacy among 1,000 subjects, including 750 VLP recipients and 250 placebo recipients. In case there are favourable results from the first stage, the second stage of the study will be initiated to evaluate the safety of the vaccine in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The primary safety and immunogenicity results are expected within 3 months of the start of this study in January 2010. If the results are clinically acceptable, they will be used to seek registration of Novavax’s 2009 H1N1 pandemic flu vaccine in Mexico. These data are also expected to support development of the company’s pandemic and seasonal flu VLP vaccines in other countries, including the United States.
Thomas Johnston, vice president of Strategy at Novavax, said: “This study is a continuation of our efforts to respond quickly to this current pandemic by leveraging our proprietary recombinant VLP technology and our innovative manufacturing solution. We appreciate having the opportunity and support to demonstrate the H1N1 vaccine’s safety, immunogenicity and efficacy in Mexico and thereby help with ongoing pandemic response efforts. Similar to our previous announcements regarding our ongoing work in the countries of India and Spain, where we plan to establish in-border production, our planned clinical work in Mexico, if successful, could lead to rapid availability of the vaccine and advance Novavax’s regional strategy to assist countries around the globe with such critical needs.”