Novavax Says Beginning Phase 1 Clinical Trial of RSV Vaccine Candidate

Novavax, Inc. NVAX 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.