Novovax, Inc. begins phase IIa testing of seasonal influenza vaccine. This rapid seasonal influenza virus-like particel (VLP) vaccine trial enrollment positions the company to report data in fourth quarter of this year.

Novovax today announced the vaccination of healthy volunteers in their phase II clinical trial of a VLP based seasonal influenza vaccine. VLP are recombinant structures which, although very much like viruses, lack genetic material and are, as such, unable to replicate. They induce relevant immune responses due to their similarity to infectious proteins and are as a result, potentially very significant in vaccine composition.

The clinical trial, which will be randomized and placebo-controlled will evaluate the safety and immunogenicity of different doses of its seasonal influenza VLP vaccine and will be studied in approximately 300 healthy adults between the ages of 18 to 49 years. These adults will receive a single injection of either a placebo or an influenza vaccine at doses of 5 mcg, 15 mcg or 30 mcg. 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.

The VLP includes three viral proteins (incorporated in the vaccine as three separate VLPs) important for inducing a broad immune response including two surface proteins, hemmaglutinin (HA) and neuraminidase (NA), and a core matrix protein, M1. NA’s properties have the potential for educing symptom severity and responses to MI may lead to the destruction of already infected cells. Additionally, the vaccine itself is made in cell culture, resulting in an exact genetic match to existent flu strains.

The company’s manufacturing process makes it possible to produce vaccines containing strains that are exact genetic matches to the strains found within the population in approximately half the time that is currently required. This could be important in a number of ways, including providing appropriate vaccinations for children even before the school year begins.

Source: Novavax, Inc.