ROCKVILLE, Md., March 29 /PRNewswire-FirstCall/ -- Novavax, Inc. a clinical-stage vaccine company, released the final results from a Phase II clinical trial evaluating Novavax's trivalent seasonal influenza 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.
Preliminary HAI results from this study were presented at the 47(th) Annual Meeting of the Infectious Diseases Society of America (IDSA) on October 31, 2009 and were described in a company press release dated November 2, 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. For volunteers in the 15 mcg group, seroconversion rates (greater than or equal to 4-fold rise in titer from baseline) with the accompanying 95% CI were 57% (44, 68), 86% (75, 93), and 62% (50, 74) against the H1N1, H3N2, and B strains, respectively. For volunteers in the 15 mcg group, seroprotection rates (titer greater than or equal to 1:40) with 95% CI were 67% (54, 78), 91% (82, 97), and 84% (73, 92) against the H1N1, H3N2, and B strains, respectively. In the final results reported today, the H3N2 and B strain data in the 15 mcg VLP dose met the FDA seroconversion guidelines of 40 (lower 95% CI) while the H1N1 data fell just short (39.4 versus 40.0). However, the mean seroprotection rate against the H1N1 strain rose slightly from an original 67% to a final 70%.
"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," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "We will continue measurement of NAI activity in other clinical trials since we believe that the ability of the VLP vaccine to elicit an NAI response may differentiate our vaccine from others. These NAI results support our position that VLP influenza vaccines have the potential to induce a broad-based immune response that could lead to improved clinical outcomes. We now await comparative immunological and safety data from a larger head to head clinical trial in older adults (>60 years of age) between TIV and our VLP vaccine," said Dr. Singhvi.
About Novavax
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. Additional information about Novavax is available on the company's website: www.novavax.com.
Novavax, Inc.
