Date: 2015-08-10
Type of
information: Results
phase: 2
Announcement: results
Company: Novavax (USA - MD)
Product: RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine)
Action
mechanism: protein/vaccine.
Disease: Respiratory Syncytial Virus (RSV) infection
Therapeutic
area: Infectious diseases
Country: USA
Trial
details:
Latest
news:
- • On August 10, 2015, Novavax, a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, announced positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older). The RSV F Vaccine was well-tolerated and fulfilled the Company’s expectations of the primary, secondary and exploratory objectives of the trial.
- The Novavax trial was a randomized, observer-blinded, placebo-controlled Phase 2 trial of 1,600 older adult participants conducted at 10 sites in the United States. The trial was designed to prospectively examine the incidence of all symptomatic respiratory illnesses associated with RSV, in community-living older adults who where treated with placebo. The trial also evaluated safety and immunogenicity of the unadjuvanted, 135 µg dose of the RSV F Vaccine compared to placebo. Finally, the trial estimated the efficacy of the RSV F Vaccine in reducing the incidence of respiratory illness due to RSV.
- The trial is the first to demonstrate efficacy of an active RSV immunization in any clinical trial population, and showed statistically significant vaccine efficacy in prevention of all symptomatic RSV disease (44%) and RSV disease with symptoms of lower respiratory tract infection (46%) in older adults. The observed efficacy was similar to or better than multiple recent effectiveness estimates for a number of licensed respiratory vaccines tested in older adults including pneumococcal and standard-dose seasonal influenza. The trial also established an attack rate for symptomatic RSV disease of 4.9% in older adults, 95% of which included lower respiratory track symptoms, and confirmed the significant burden of RSV disease in this population. In addition, statistically significant efficacy against more severe RSV illness, as defined by the presence of multiple lower respiratory tract symptoms associated with difficulty breathing, was 64% in several ad hoc analyses. Kaplan-Meier curves showed continued divergence of active vaccinees from placebo recipients over the nearly 6 months during which RSV was detected, demonstrating the durability of protection throughout the RSV season.
- As expected from the Company’s prior trials, anti-F IgG and palivizumab-competing antibody (PCA) titers peaked rapidly at day 14, plateaued at day 28 and remained at elevated levels through day 56; the last time point currently analyzed. There were greater than four-fold increases in both anti-F IgG and PCA concentrations at trial days 14, 28 and 56, and serologic responses in over 90% of vaccinated subjects, indicating a robust immune response, similar to the findings from the Company’s prior trial in older adults. Finally, the safety profile in vaccine recipients was nearly identical to that of placebo recipients with regard to both local and systemic events. Novavax now intends to initiate a pivotal phase 3 trial.
Is
general: Yes
