Initiation of a phase III clinical trial of MVA BN RSV vaccine in older adults.
Bavarian Nordic A/S announced the dosing of the first subject in the Phase III VANIR clinical trial of its investigational respiratory syncytial virus (RSV) vaccine candidate, MVA BN RSV in older adults.
The VANIR trial is a global, randomized, double-blind Phase III trial of the recombinant MVA BN RSV vaccine in 20,000 adults aged 60 years and older. The primary objective of the study will assess the efficacy of the vaccine candidate against lower-respiratory tract disease caused by RSV compared to placebo.
The Phase III trial is being conducted at approximately 115 sites across the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023 with topline results expected mid 2023 if the pre-defined number of lower-respiratory tract disease events has occurred.