Novavax completes enrollment in Phase IIa influenza vaccine trial

The Phase IIa randomized, placebo-controlled clinical trial is evaluating the safety and immunogenicity of different doses of its seasonal influenza virus-like particle (VLP) vaccine.

Specifically, the vaccine will be studied in approximately 300 healthy adults between the ages of 18 and 49 years, who will receive a single injection of either a placebo or an influenza vaccine at doses of 5mcg, 15mcg or 30mcg. The goals of the study are to select a dose for evaluation in a subsequent Phase III efficacy study and to continue the evaluation of safety of its novel influenza VLP vaccines.

VLPs are recombinant structures that mimic the size and shape of a virus but lack genetic material and are therefore incapable of replication. Because they resemble actual infectious particles presenting proteins in the same conformation as on the wild-type virus, they are able to induce potent immune response.

Rahul Singhvi, president and CEO of Novavax, said: “The completion of enrollment for this critical clinical trial within a week of its initiation should enable us to release top line data from this study in the fourth quarter of 2008. I congratulate our team on this accomplishment and for advancing two novel influenza vaccines into Phase II development this year.”