Novavax recently announced positive data from a Phase 2 RSV F-Protein vaccine clinical trial in older adults. The company’s respiratory syncytial virus (RSV) vaccine showed efficacy in the entire population of study subjects, revealing significant vaccine efficacy in preventing symptomatic RSV disease in the prospective RSV epidemiological study that also noted a seasonal attack rate of 4.9 percent for the symptomatic form of the disease.
Novavax, Inc. is a clinical-stage vaccine firm developing and marketing recombinant nano particle vaccines and adjuvants. The company recently announced positive outcomes of the RSV F-protein recombinant nanoparticle vaccine in older adults 60 years of age and older. The vaccine met the company’s expectations and it was well-tolerated among study participants.
William Schaffner, Professor at the Vanderbilt University Medical Center, said: “It’s increasingly appreciated that RSV causes an enormous amount of illness on an annual basis, particularly in the older population. An RSV infection can predispose older adults to developing secondary pneumonia and admission to the hospital. Each year in the United States, approximately 14,000 people ages 65 or older die of RSV infections and approximately 900,000 have some sort of medical encounter with a doctor, or emergency room, or are hospitalized. Prevention remains the highest goal of medicine and those of us in preventative medicine and public health would like to prevent as many of these infections as possible.”
The randomized, blinded and placebo controlled Phase 2 trial included 1,600 older adult participants tested at 10 locations in the US and was designed to assess the incidence of all symptomatic respiratory diseases that are connected to RSV in older adults. The trial assessed safety and immunogenicity of the 135 microgram dose of RSV F Vaccine in comparison to placebo. The goal of the study was to estimate the efficacy of the vaccine in reducing the incidence of respiratory illness caused by RSV.
The trial showed significant vaccine efficacy in older adults in preventing symptomatic RSV disease (44 percent) and RSV disease with symptoms of the lower respiratory tract infection (46 percent). Efficacy was even better than several recent estimates of respiratory vaccines that include pneumococcal and standard-dose seasonal influenza. Researchers noticed an attack rate for symptomatic RSV disease of 4.9 percent in older adults and 95 percent of those included lower respiratory track symptoms and emphasized the significant burden of RSV disease in the older population segment. Multiple lower respiratory tract symptoms linked with breathing issues was 64 percent in multiple ad hoc analyses, and a 6-month vaccine protection throughout the RSV season was demonstrated as well.
An increase in both amount of anti-F IgG and PCA concentrations and in serologic responses in more than 90 percent of vaccinated subjects revealed a strong immune response. “These efficacy data represent a historic advance for the field. This is also an important confirmation of the burden of RSV disease in older adults and highlights the high rate of lower respiratory tract symptoms in those infected by RSV in a large, prospective trial. It is clear that our RSV F Vaccine provided statistically significant efficacy in older adults, a population that historically has been difficult to protect. The reduction in symptomatic RSV, RSV with lower respiratory tract illness and RSV associated with difficulty breathing are breakthrough results. We look forward to making details of these data public at an appropriate forum in the future,” added Gregory Glenn, Senior Vice President, Research and Development.
“The development of an RSV vaccine has been a decades-long challenge,” stated Stanley C. Erck, President and CEO. “We are thrilled by the groundbreaking efficacy of our RSV F Vaccine in older adults. We are committed to pursuing an aggressive developmental timeline for this program which includes discussions with regulatory authorities and initiation of a pivotal Phase 3 trial as early as the fourth quarter of this year. We also expect to announce safety and immunogenicity data from the RSV F Vaccine Phase 2 trial to protect infants via maternal immunization later this quarter.”