Novavax’s trivalent seasonal influenza VLP vaccine has been shown safe and effective in controlling three strains of flu virus in phase 2 studies.
Novavax, Inc released the final results from a phase 2 clinical trial evaluating virus-like particle (VLP) vaccine candidate in healthy adults.
The study enrolled healthy volunteers 18 to 49 years in age who were immunized with a single injection of Novavax’s trivalent seasonal influenza VLP vaccine matched to the influenza strains recommended for the 2008-2009 influenza vaccine. Preliminary data from this trial were reported in 2009.
The complete analysis included 232 volunteers in total; with 49 receiving placebo, 83 given Novavax’s trivalent seasonal influenza VLP vaccine at 15 mcg/dose, 81 injected with 60 mcg/dose and 19 volunteers receiving an inactivated trivalent influenza vaccine Fluzone (TIV) by Sanofi Pasteur at 15 mcg/dose.
The three strains were H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida/04/2006. The data show that Novavax’s trivalent seasonal influenza VLP vaccine induced a robust hemagglutination inhibition (HAI) antibody response against all three strains in the vaccine.
Preliminary HAI results from this study were presented at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) on October 31, 2009.
Those interim results were based on evaluation of a total of 190 volunteers, of which 37 received placebo, 69 received trivalent seasonal influenza VLP vaccine at 15 mcg/dose, 67 received trivalent seasonal influenza VLP vaccine at 60 mcg/dose and 17 received TIV.
Novavax vaccine trials also measured functional antibody against the neuraminidase enzyme in the sera of immunized subjects using a neuraminidase inhibition assay (NAI).
Inhibition of neuraminidase activity may be important in reducing the spread and severity of influenza infection.
Novavax tested volunteers for NAI against B/Florida, H3N2/Brisbane and H1N1/Brisbane components of the vaccine before and after immunization. Against the B strain, 59% of the patients receiving the 15 mcg dose of VLP showed a 4-fold or higher rise in NAI titers over pre-immune levels.
At the 60 mcg VLP dose, 73% had a 4-fold rise while only one subject (5%) from the TIV population had a 4-fold rise. In the NAI assay against the H3N2 strain, 50% of the patients immunized with the 15 mcg VLP dose had a 4-fold rise in NAI titers.
At the 60 mcg VLP dose, 56% had a 4-fold rise. In the small subset of subjects tested against H1N1 NAI activity (10 placebo and 20 at the 60 mcg VLP dose), the NAI in the VLP treated group increased about 30% over preimmunization levels while the placebo treated group had no increase over pre-immunization levels.
“The data released today show that our VLP influenza vaccine not only induces a robust HAI response but also enhances the NAI response far above that induced by TIV,” stated Dr. Rahul Singhvi, president and chief executive officer of Novavax.
Novavax will continue measurement of NAI activity in other clinical trials since the company believes that the ability of the VLP vaccine to elicit an NAI response may differentiate its vaccine from others, he added.
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection.
VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology.
Novavax VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology.
The company produces potent VLP -based, recombinant vaccines utilizing new and efficient manufacturing approaches.
Novavax is committed to using its VLP technology to create country-specific vaccine solutions.
It launched in 2009 a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India.