Novavax Initiates Phase 2 Safety and Immunogenicity Trial of the RSV F Vaccine in Older Adults

GAITHERSBURG, Md., Jan. 19, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced the initiation of a Phase 2 clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older).

The objective of the trial is to assess safety and immunogenicity to one and two dose regimens of the RSV F Vaccine, with and without aluminum phosphate or Novavax' proprietary Matrix-M(TM) adjuvant, in older adults. The trial is a randomized, observer-blinded, placebo-controlled trial designed to enroll up to 300 older adults in the Southern Hemisphere. Participants are being enrolled and vaccinated outside of the RSV season to best assess immunogenicity. Top-line results are expected in the third quarter of 2017.

"We believe that a more immunogenic vaccine in the older adult population should translate into a more efficacious vaccine," said Stanley C. Erck, President and CEO. "We expect the results from this trial to inform the next steps in our older adults program, and would ensure we maintain our leadership position in this very attractive market opportunity."

About RSV

Respiratory syncytial virus, commonly referred to as RSV, is a respiratory infectious disease that causes serious infection of the respiratory tract, similar to influenza. For some, RSV may progress in severity, and lead to hospitalization or even death. The spread of RSV occurs annually, with an incidence rate of 2.5 million infections per year in the United States, RSV is increasingly being recognized as a significant cause of morbidity and mortality in the population of 64 million older adults.(1,2) Each year, RSV is responsible for approximately 207,000 hospitalizations and 16,000 deaths among adults older than 65.(1,3) Annually, there are approximately 900,000 medical interventions directly caused by RSV disease.(4,5) Currently, there is no approved RSV vaccine available.

About Matrix-M

Matrix-M(TM) is a next-generation, patented adjuvant comprised of purified saponin fractions mixed with synthetic cholesterol and a phospholipid to form stable particles than can be readily formulated with a variety of vaccine antigens. Saponin-based adjuvants act in part by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in the local lymph nodes. Thus, Matrix-M(TM) induces both a cell-mediated and antibody mediated immune response.  Matrix-M is manufactured by Novavax, Inc., in Uppsala Sweden.