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Novavax Announces Top Line Results of Phase IIa Clinical Trial for Its Seasonal Influenza VLP (Trivalent) Vaccine Candidate
Date:12/11/2008

94% for H1N1, and 73 to 79% for B. Seroconversion rates (i.e., percentage of subjects with greater than or equal to 4 fold rise in HAI titer from baseline) ranged from 90 to 100% for H3N2, 69 to 78% for H1N1, and 42 to 56% for B among subjects who did not have antibodies to these strains before vaccination. The geometric mean HAI titers were strong and increased with dose. High HAI titers, similar to those seen with the vaccine strains, were also observed against drifted H3N2 and H1N1 strains, demonstrating the potential for the vaccine to be cross-protective.

The current data strongly support continued development of the vaccine. Additional studies of Novavax's seasonal influenza VLP vaccine in healthy adults and subsequently in older adults greater than or equal to 65 years of age in the second half of 2009 to evaluate dosing and further study the safety and immunogenicity of the VLP vaccine as compared with a currently licensed influenza vaccine.

"We are very pleased with the results from this human clinical trial for our seasonal influenza vaccine program," said Dr. Rahul Singhvi, President and CEO of Novavax. "Our VLP technology continues to show promise as an approach against influenza. These seasonal influenza results in combination with the pandemic influenza results released in August of this year, give us ongoing confidence in this technology in preventing influenza. The accumulating immunogenicity data from our preclinical and clinical studies suggest that VLPs may be broadly immunogenic, inducing not only anti-HA responses but also anti-neuraminidase and cell mediated immune responses. We believe these attributes of the VLP vaccine may offer a new approach for a differentiated vaccine to address unmet medical needs related to influenza prevention in elderly patients."

What makes Novavax's seasonal vaccine different

VLPs are recombinant structures that mi
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SOURCE Novavax, Inc.
Copyright©2008 PR Newswire.
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