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NOVAVAX Announces Positive Preclinical Results for its Respiratory Syncytial Virus (RSV) Vaccine Candidate
Date:1/12/2010

ROCKVILLE, Md., Jan. 12 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that it has successfully completed a pre-clinical safety and efficacy study of its RSV vaccine candidate in cotton rats.  Results from this study are needed to support an Investigational New Drug (IND) application to advance this novel recombinant F protein particle based RSV (RSV-F) vaccine candidate into clinical development.  This vaccine candidate is composed of recombinant 'F' or 'fusion' protein of RSV which is used by the virus to infect and fuse with cells in the respiratory tract and cause disease.  

In the current study, Novavax tested its RSV-F vaccine candidate in cotton rats, a well accepted animal model for RSV infection and disease.  The animals received two injections on days one and 21 with 1, 6 or 30 micrograms of RSV-F vaccine with or without an alum adjuvant.  All dose groups produced antibodies that neutralize RSV, and with adjuvant, only a single injection of RSV-F was needed to induce high levels of neutralizing antibodies.  The immunized cotton rats were challenged with live RSV to test if they were protected from infection.  High levels of virus were measured in unimmunized control animals but no RSV was detected in the lungs of animals immunized with any dose of the Novavax RSV-F vaccine, with or without adjuvant.  

RSV vaccines require a heightened evaluation of safety because of a failed study in children in the mid-1960s with a formalin-inactivated RSV vaccine candidate that caused enhancement of the disease.  In the current study, the lungs of RSV challenged cotton rats were examined and there was no sign that immunization with the Novavax RSV-F vaccine candidate resulted in enhance
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SOURCE Novavax, Inc.
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