By Cameron Chai
Louis F. Fries III, Vice President of Clinical and Medical Affairs at Novavax, will present the Phase I clinical study results of the company’s recombinant nanoparticle vaccine candidate for respiratory syncytial virus (RSV) at the XIV International Symposium on Respiratory Viral Infections to be conducted from March 24 to 26, 2012 in Istanbul, Turkey.
The Phase I clinical trial was a blinded, placebo-controlled, escalating-dose study. At the conference, Dr. Fries will deliver the study results in separate oral and poster presentations.
Dr. Fries informed that during the conference, Novavax will describe the safety of RSV nanoparticle vaccine in young adults for short-time and six-month periods. It will also discuss the vaccine’s immunogenicity in terms of virus neutralization activity and other immune assessments that may be related to the safety against RSV, which causes respiratory diseases in children, and mortality and morbidity in elder people worldwide. The study results are positive and demonstrate the potential of the RSV nanoparticle vaccine candidate to offer the type and level of immunity needed to protect these age groups.
Novavax released interim results of this study in October 2011. The findings were in line with the preclinical studies and demonstrated that the RSV nanoparticle vaccine was highly immunogenic, well-tolerated, and generated functional antibodies, which neutralized RSV.
Novavax plans to start two separate Phase II dose-ranging studies of the RSV nanoparticle vaccine in women of child-bearing age and in elder people. These two separate studies will be carried out with or without an adjuvant, and will deliver both immunogenicity and safety results of the vaccine in these different age groups.