Novavax, Inc. today announced that enrollment has begun in a Phase 2 dose-confirmatory clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age.
This randomized, blinded, placebo-controlled Phase 2 study will evaluate the immunogenicity and safety of multiple formulations of Novavax' RSV-F protein nanoparticle vaccine candidate with aluminum phosphate as an adjuvant. The study is scheduled to enroll 720 women of childbearing age who will receive either one or two intramuscular injections at each dose level of vaccine or placebo at days 0 and 28. Immunogenicity and safety will be evaluated over three month and six month periods, respectively.
"This trial represents important progress for our RSV vaccine, which is being developed to protect young infants through maternal immunization," said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. "This study will help define the dose and dose regimen and expand the safety database for our maternal immunization strategy. These are all essential steps in the advancement of this important vaccine towards licensure."
RSV is a respiratory pathogen that afflicts all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. It is estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available for either of these populations.
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 protein 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.