In Part A of the study, a single injection of the H1N1 Influenza VLP vaccine at doses of 5mcg, 15mcg, and 45mcg induced immune responses against the H1N1 viral strain that met the Food and Drug Administration (FDA) immunogenicity criteria for licensure of seasonal inactivated influenza vaccines. A dose-response was observed as measured by the HAI assay. At Day 14, the rates of seroconversion for the 5mcg, 15mcg, and 45mcg dosage groups were 48.3%, 65.0%, and 74.9%, respectively, as compared to 5.9% for the placebo group. Similarly, at day 14, the proportion of subjects who achieved an HAI titer greater than or equal to 1:40 (seroprotection) for the 5mcg, 15mcg, and 45mcg dosage groups increased to 81.6%, 90.5%, and 91.6%, respectively. The second vaccine administration at day 21 did not significantly change the seroconversion and seroprotection rates.
Approximately 40% of all subjects had a baseline HAI titer greater than or equal to 1:40 to H1N1 at day 0, either due to exposure to the ongoing pandemic virus, or past exposure. Therefore, a sub-analysis was performed in subjects who were H1N1 seronegative at baseline. In this population, the seroconversion rates for the 5mcg, 15mcg and 45mcg groups were, 64%, 79% and 85%, respectively, after the first dose.
Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company's proprietary virus-like particle (VLP) technology and unique disposable system enables rapid vaccine development and production where and when it's needed, worldwide. The company has formed a joint venture with C
|SOURCE Novavax, Inc.|
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