Novavax Initiates Phase 1 Clinical Trial of RSV F Vaccine in Pediatric Subjects

GAITHERSBURG, Md., Nov. 10, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 1 clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy children, the first study of this vaccine candidate to be conducted in a pediatric population.

The trial, which is being conducted in Canada, is a randomized, observer-blinded, dose-ranging Phase 1 study to evaluate the safety and immunogenicity of the RSV F Vaccine, with or without aluminum phosphate adjuvant, in 150 healthy pediatric subjects two to six years of age. In addition to the trial's primary goal of evaluating safety in this population, the study will also evaluate immunogenicity as measured by concentrations of serum IgG antibodies to the RSV fusion, or F-protein, palivizumab-competing antibody titers and RSV microneutralization titers.

"Today's announcement of the initiation of the Phase 1 RSV F Vaccine pediatric trial, delivers on our stated goal of starting RSV F Vaccine trials in all three of our target populations, during the third and fourth quarters of 2014. With the initiation of clinical trials in pregnant women, elderly subjects and children, we position our RSV F Vaccine franchise to deliver important clinical results in the second and third quarter of 2015," said Stanley C. Erck, President and CEO of Novavax.

"RSV is a significant cause of pediatric respiratory disease, including pneumonia, bronchiolitis and recurrent wheezing. The ability to prevent RSV-related lower respiratory disease in the pediatric population via immunization is an important public health goal," said Dr. Gregory Glenn, SVP, Research and Development at Novavax. "We believe this clinical trial is an important step forward in addressing that goal."

About RSV

RSV is a major respiratory pathogen with a significant burden of disease in the very young and in the elderly. 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. In infants, toddlers and young pre-school and school-age children, RSV infections result in the need for frequent medical care, including ER and office visits and are associated with increased recurrent wheezing that can persist for years. It is also estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection or its complications annually in the U.S., and up to 180,000 are hospitalized for serious respiratory symptoms. Currently, there is no approved RSV vaccine available for any of these populations.