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 (RSV) F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy elderly subjects.
The trial is a randomized, observer-blinded, placebo-controlled Phase 2 study scheduled to enroll 1,600 elderly subjects (>60 years of age) at ten sites in the United States. The trial will evaluate the incidence of all respiratory illnesses due to RSV, including medically-attended respiratory illnesses due to RSV, and hospitalizations for respiratory illness due to RSV in community-living elderly adults who have been treated with placebo. The study will also evaluate the safety and immunogenicity of a 135µg dose of the RSV F Vaccine compared with placebo. The trial will also estimate the efficacy of the RSV F Vaccine in reducing the incidence of respiratory illnesses due to RSV.
"The initiation of this elderly clinical trial, shortly after the initiation of our Phase 2 maternal immunization trial last month, demonstrates our commitment to the strategy of building an RSV franchise. The goal of that strategy is to maximize the value of this product candidate for susceptible populations, the medical community, and our shareholders," said Stanley C. Erck, President and CEO of Novavax, Inc. "Today there is a significant unmet medical need for an RSV vaccine for the approximately 57 million individuals over the age of 60 in the US. This suggests that the elderly market may be the largest value driver in our RSV franchise."
"RSV is increasingly recognized by the medical and scientific community as a pathogen of great importance in the elderly population. This key study will evaluate RSV respiratory illness incidence rates in the elderly population in a prospective manner, further develop our safety and immunogenicity database in older adults and provide an estimate of the RSV F Vaccine's efficacy. Answers to these questions will inform the design of our projected Phase 3 pivotal study," said Greg Glenn, SVP, Research and Development at Novavax, Inc. "It is our goal to commence three RSV clinical trials in the fourth quarter, furthering the development of our RSV F Vaccine in each of the three key target populations: young infants via maternal immunization, children beyond infancy, and the elderly. We look forward to initiation of our Phase 1 Pediatric RSV study later this quarter."
Source: http://www.novavax.com/