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Vaccine candidates met safety and immunogenicity endpoints in both trials
Trials' results support further development of vaccine in larger trials -- Adjuvanted candidates, at all doses of antigen tested including 3.75 µg dose, achieved dose-sparing goals with seroconversion and seroprotection rates from 86% to 100% -- Unadjuvanted vaccine candidate, at 45 µg dose, achieved >82% seroconversion and seroprotection in both trials -- Phase 1 results fulfill FDA criteria for accelerated approval; future confirmatory trials planned
Cross-reactive antibody responses observed for a second strain of A/H5N1
ROCKVILLE, Md., Oct. 17, 2012 (GLOBE NEWSWIRE)
-- Novavax, Inc. (Nasdaq:NVAX) today reported positive top-line results from two Phase 1 clinical trials of its A/H5N1 avian influenza vaccine candidate administered alone or with either one of two undisclosed adjuvants. The trials' primary objectives of demonstrating the safety and immunogenicity of varying dose-levels of the vaccine, with and without adjuvant, and the demonstration of statistically significant adjuvant effects on the immune responses were achieved. The vaccine safety was acceptable with no vaccine-related serious adverse events observed.
Stanley C. Erck, President and CEO of Novavax, stated, "The data from these trials represent a landmark event in the history of Novavax. We have demonstrated that Novavax can produce antigens from avian influenza strains that are as, or more, immunogenic than any other described in published results to date. Importantly, as we accelerate our development activities, these results give us tremendous flexibility for pursuing pandemic vaccine products, including vaccines directed at population segments that are sensitive to adjuvant use."
The two randomized, observer-blind, dose-ranging, placebo-controlled Phase 1 trials were conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). The primary objectives of the two trials were to demonstrate the safety and immunogenicity of Novavax' VLP-based H5N1 vaccine candidate at varying dose-levels, with and without an adjuvant, using identical clinical study designs but with a different adjuvant in each study. A total of 666 healthy adults 18 to 49 years old were enrolled in the two trials. Each subject received intramuscular injections of vaccine or placebo at day 0 and day 21, and will be followed for 13 months following the first dose. The current data relate to safety and immune responses over the first 42 days.