|Novavax Announces Publication Of Results From H5N1 Influenza Virus-Like Particle Vaccine.|
|By Staff and Wire Reports|
|Thursday, 08 September 2011 19:50|
Novavax, Inc. (NASDAQ:NVAX), announced new safety, immunogenicity and cross-reactivity results from a Phase I/IIa clinical study of the Company's H5N1 influenza virus-like particle (VLP) vaccine candidate that was conducted in 2008.
According to the report in the current issue of Journal of Virology, Novavax's VLP-based vaccine targeted against a highly pathogenic avian H5N1 influenza virus was well-tolerated, produced no vaccine-related serious adverse events and induced neutralizing antibodies that were cross-reactive with different avian A/H5N1 influenza viruses.
This is the first report of a unadjuvanted vaccine inducing cross-reactive neutralizing antibodies against multiple clades of H5N1 influenza virus. Novavax's A/H5N1 VLP influenza vaccine candidate was administered to 230 adults immunized with two injections of 15, 45 or 90 micrograms of vaccine; the 2008 study was blinded, randomized and placebo-controlled.
Recent analyses show that there was a dose-related immune response and 40%, 57% and 61% of the subjects developed a four-fold or higher increase in hemagglutination inhibition (HAI) and 39%, 52% and 76% of the subjects developed a four-fold rise in microneutralizing (MN) antibodies to the 15, 45 and 90 microgram dose, respectively.
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