Novavax (NVAX) Begins Phase IIa of Flu VLP Vaccine Candidate in Adults 60 and Over
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Novavax, Inc. (NASDAQ: NVAX) has begun a Phase IIa clinical study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults 60 years of age or older. This randomized, double-blind, active-controlled study is evaluating the safety, tolerability and immunogenicity of two different doses of Novavax's trivalent seasonal influenza VLP vaccine compared with that of a commercially available trivalent inactivated vaccine (TIV, Fluzone). Novavax's vaccine contains VLPs made up of the hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins against the H3N2, H1N1, and B strains recommended for 2009-2010 influenza vaccines.
"This is a very important study because it will help establish the safety and immunogenicity of our trivalent seasonal influenza VLP vaccine in older adults and allow us to select a dose for a future Phase IIb confirmatory, non-inferiority clinical trial in this population. Moreover, it will also give us a clear signal of how our seasonal influenza VLP vaccine compares to the current standard of care, TIV (Fluzone®)," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "Recall that in a recent Phase II study in healthy adults ranging in ages from 18-49 years, we showed that our seasonal influenza VLP vaccine was safe and immunogenic at 15 and 60 mcg dose levels. These data give us great confidence as we move forward in this current clinical trial in older adults."
The current trial is a Phase IIa randomized, double-blind, active-controlled study to evaluate the safety, tolerability and immunogenicity of the trivalent seasonal influenza VLP at 15 mcg and 60 mcg per strain in healthy adults who are 60 years of age or older. The safety and immunogenicity of the influenza VLP vaccine at these two dose levels will also be compared with that of a commercially available inactivated trivalent seasonal influenza vaccine, TIV (Fluzone), administered at the standard dose of 15 mcg of HA per strain. A total of 480 subjects will be enrolled, in a 1:1:1 randomization schedule (160 subjects in each of the three arms) at approximately six sites in the United States and one site in India. In addition to evaluating hemagglutinin inhibition (HAI) responses, anti-neuraminidase and cell-mediated immune responses will also be examined. Preclinical studies have shown that influenza VLP vaccines drive stronger T-cell responses than TIV (Fluzone), indicating the potential for better immunologic responses in clinical trials particularly in older adults.
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NVAX
Hope on Nov 10, 2009 09:47 AMI do have NVAX just so you'll know. I just would like to know why NVAX is not being used for it's way of producing vaxcines without using eggs. HELLO!!!!!!