ROCKVILLE, Md., Nov. 16 /PRNewswire-FirstCall/ -- Novavax, Inc. announced today that enrollment has been completed in the first stage of a two-stage clinical study of its novel 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in the country of Mexico. An independent data and safety monitoring board has reviewed preliminary safety data from the first half of this cohort and recommended that this first stage continue as planned. The study is being conducted in Mexico City in collaboration with Avimex Laboratories. The first stage of the study is evaluating the vaccine’s safety, immunogenicity and exploratory efficacy among 1,000 healthy adults, including 750 VLP vaccine recipients and 250 placebo recipients. The results of this phase of the blinded, dose-ranging placebo-controlled study will be used to select a dose for evaluation in the second stage of the clinical study in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The results of this study will be used to support registration of Novavax’s 2009 H1N1 VLP pandemic influenza vaccine in Mexico as well as in the future development of Novavax’s pandemic and seasonal influenza vaccines in other countries.
About VLPs
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax’s VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
About Novavax
Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company’s website: www.novavax.com.
Novavax, Inc.
