Novavax, today announced that enrollment has begun in a Phase 1 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adults 60 years of age and older.
This randomized, blinded, placebo-controlled Phase 1 study will evaluate the immunogenicity and safety of two doses of Novavax' RSV-F nanoparticle protein micelle vaccine candidate with and without aluminum phosphate as an adjuvant. The study is similar to the recently launched Phase 2 RSV study in women of childbearing age but will enroll 220 adults 60 years of age and older who will receive a single intramuscular injection of Novavax' RSV-F nanoparticle protein micelle vaccine or placebo plus a single dose of licensed influenza vaccine or placebo at days 0 and 28. Safety and immunogenicity will be evaluated for up to one year.
"Respiratory syncytial virus is a frequent cause of winter respiratory illnesses in the elderly and in some seasons can equal or exceed influenza's rates of disease requiring medical attention. This study extends our clinical program designed to meet this population's need for an RSV vaccine. The study will evaluate the safety and immunogenicity of our RSV vaccine candidate in elderly adults and will help us determine the optimal dosing regimen for future studies," said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. "We expect to report top-line results from this study in the second quarter of 2013."