RSV F vaccine: Phase II data
Top-line data from an observer-blinded, U.S. Phase II trial in 1,600 community-living adults ages >=60 showed that 135 ug RSV F Vaccine without adjuvant met a pre-specified exploratory efficacy outcome of reducing the incidence of all symptomatic RSV disease vs. placebo. Specifically, the vaccine reduced the relative risk of all symptomatic RSV infections by 43.9% vs. placebo (21 vs. 38 cases). The vaccine also reduced the relative risk of RSV lower respiratory tract infections by 46.4% vs. placebo (19 vs. 36 cases, p=0.03). Additionally, there was a 4.8-fold increase in anti-F IgG concentrations in vaccinated subjects vs. placebo. An ad hoc analysis showed that the RSV F Vaccine reduced the risk of more severe RSV illness, defined by the presence of multiple lower respiratory tract symptoms associated with difficulty breathing, by 64% vs. placebo. ...