Novavax has kicked off a two-stage clinical study of its virus-like-particle (VLP) H1N1 influenza (swine flu) vaccine in Mexico, in collaboration with Avimex Laboratories and GE Healthcare.

The first stage will evaluate the vaccine’s safety, immunogenicity and efficacy among 1,000 subjects, including 750 VLP recipients and 250 placebo recipients.

Depending on the success of the first stage, the second stage will be used to evaluate the safety of the vaccine in a much larger group of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients).

Novavax president and CEO Dr Rahul Singhvi said that this clinical study represents a unique opportunity to accelerate the development of the vaccine.

“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 the vaccine,” Singhvi said.

Avimex will provide financial support for the trial and is expected to distribute the H1N1 VLP vaccine in Mexico in 2010 if it is approved. GE Healthcare’s contribution will be to continue providing its single-use bioprocessing technologies for vaccine production.

Trial results are expected within three months of the start in January 2010. Depending on the outcome, the data will be used to seek registration for the flu vaccine in Mexico, which the company hopes will pave the way for approval in other countries, including the US.