Novavax Study Published in Vaccine

RSV F-Protein Nanoparticle Vaccine Induces Antigenic Site II Antibodies - Seite 2

The study employed a number of antibody assays to further explore the immunogenicity of the RSV F Vaccine and the production of vaccine-induced PCA in the cotton rat model. These studies used palivizumab as a control, to assess relative potency of the vaccine, both in active and passive assessments, and the recently available Lot 100 formalin-inactivated RSV vaccine, which historically enhanced RSV disease in clinical studies. This allowed comparative evaluation of safety, 'functional' immunity as measured by PCA and neutralization assays, and protection in this clinically relevant model. The vaccine was shown to be safe, potent, to elicit high levels of neutralizing PCA and anti-F antibodies and to be protective against both homologous strain and heterologous, or "drift", strain viral challenges. The protection seen with active immunization could be reproduced using passively injected immune sera and appeared as potent as, or more potent than palivizumab. Neither active immunization of vaccine nor passively injected immune sera were associated with disease enhancement. Finally, the RSV F Vaccine was also found to elicit antibodies that are known to bind other non-palivizumab F-protein binding sites associated with neutralization.

About RSV

RSV is a major respiratory pathogen in infants, children, and adults. RSV infections in adults represent re-infections and are generally mild to moderate in severity, except in persons with high-risk conditions including the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11,000 and 17,000 adults die of RSV infection annually in the U.S. and up to 180,000 are admitted to hospitals with respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available. Palivizumab is a monoclonal antibody, licensed and sold by MedImmune as Synagis^®, that targets the RSV F protein and is used for prophylaxis against RSV disease in high risk infants.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.