Novavax, Inc., 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 2 clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy women in the third trimester of pregnancy.
The purpose of this study is to evaluate the safety and immunogenicity of the RSV F Vaccine, in women in their third trimester of pregnancy. The trial will also assess the impact of maternal immunization on infant safety and RSV-specific antibody levels through one year and six months of life, respectively.
"Initiation of this trial represents a watershed event for Novavax and the entire vaccine industry," said Stan Erck, President and CEO of Novavax. "Our ability to deliver, on our timeline, the initiation of this landmark clinical trial is a measure of the credibility of our technology, the potential of our vaccine and most importantly, the commitment and experience of our people."
The study is a randomized, blinded, placebo-controlled Phase 2 study, which will enroll 50 healthy women in their third trimester of pregnancy (maternal subjects). Enrolled maternal subjects will be randomized to receive placebo or 120 µg of RSV F Vaccine with 0.4mg of aluminum as adjuvant. Maternal subjects will be followed through pregnancy, delivery, and for an additional 180 days postpartum to assess safety and immunogenicity as measured by serum RSV F IgG antibody concentrations, palivizumab-competing antibody titers (PCA) and microneutralization titers. Upon delivery, cord blood samples will be used to determine the concentrations of RSV F IgG antibody, PCA and microneutralization titers in the infant subject. Additional serum samples from infant subjects will be obtained over the following 6 month period, to provide a preliminary understanding of the half-life of maternal antibodies. Infant subjects will be followed for one year post-birth to assess the safety of the RSV F Vaccine in the maternal immunization setting.
"The team at Novavax is committed to improving infant health and the start of this trial is an important milestone towards our efforts to bring a safe and effective vaccine to the marketplace. RSV is a major cause of infant morbidity and mortality globally. We believe that a vaccine given during pregnancy for the benefit of the infant is the approach most likely to protect young infants, the population most vulnerable to severe disease and hospitalization due to RSV," said Greg Glenn, SVP, Research and Development at Novavax. "The initiation of this trial represents a critical inflection point in our disciplined step-by-step development plan, built on the foundation of our prior clinical safety and immunogenicity trials, the historical development of palivizumab (Synagis™), and guidance by the community of RSV experts who have provided essential advice and encouragement. Speaking on behalf of everyone at Novavax, as the project lead for this program, we are gratified to have reached this point and look forward to continued progress."
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. 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 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.